FDA Compliance

We’d be willing to bet your key collaborators aren’t all in the same building. Your team members, contract partners, clients, and suppliers are likely scattered across the globe. That makes collecting physical, “wet ink” signatures nearly impossible and turns digital approvals into a daily…

Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively.

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What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?

It’s a compelling vision—and one that’s becoming increasingly achievable through AI-enabled automation. But let’s be clear: We’re not there yet.…

A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety. It means that whenever we change a factor in a cause-and-effect diagram (e.g., machine, material, manpower, method, measurement, environment, or any other factor), we create risks of…

Imagine you’re a student trying to pass a challenging class, one where the entire grade rests on the big test at the end of the semester. Fortunately, the professor handed out a syllabus that outlines exactly what will be on that final exam. Better still, you can also find a posted list of…

Take two aspirin and call me in the morning: If only prescribing medications were as simple as that.

In reality, the prescription process involves many players and steps. Details must be accurately spelled out, interpreted, and double-checked to ensure patients get the correct…

In medical technology, safety is paramount. Every step in the manufacturing process must meet the highest standards, from patient protection to regulatory compliance. Because direct part marking plays a key role in ensuring traceability and unique device identification (UDI) conformity, it’s…

A rapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders. These drugs, which usually take the form of large protein molecules, are manufactured by growing living cells that are genetically engineered to produce the…

Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices…

Good supplier management is one of the most important methods of building a safe and effective medical device. A single device may be made up of dozens of parts and components coming from several different suppliers, and many medical device companies outsource the manufacturing of their device…

The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and…

A global food safety and quality certification, BRCGS (British Retail Consortium Global Standards) initially focused on food safety but now comprises various sectors such as packaging, consumer products, and retail. It aims to ensure that businesses maintain high standards of safety and quality…

As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF):
• “AI-enabled…

According to the U.S. News & World Report article “FDA Warns Sanofi of Manufacturing Irregularities at Key Facility” (Jan. 23, 2025), the pharmaceutical company Sanofi received a U.S. Food and Drug Administration warning letter “stating that FDA inspectors found irregularities with the…

One of the key findings in Greenlight Guru’s 2025 Medical Device Industry Report was that economic uncertainty is playing a large role in the decisions medical device companies make this year.

The report surveyed more than 500 medical device professionals across quality,…

The medical device industry is growing. Data from KPMG predict that global annual sales will rise by 5% per year to reach just under $800 billion by 2030. New technology, new opportunities, and, as always, the promise of improving patient outcomes around the world are major drivers of growth…

Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.

Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the Global Medical Device Podcast to…

Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…

In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.

Since then, the industry has seen explosive growth of AI in medical device manufacturing…

Back in 2023, only 15% of businesses had adopted AI-augmented software testing tools. By 2027, that number is expected to leap to 80%. The reason behind this rapid adoption is clear. The complexity of modern software and products is skyrocketing, and with it, the risks associated with quality…

ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS). Successfully implementing ISO 27001 can provide tremendous benefits, such as ensuring data security, building trust with customers, and meeting…

Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.

Fortunately, compliance with medical device regulations and standards is not an…

In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…

While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence.

Real-world data (RWD), which typically come from routine healthcare…

In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and trustworthy.

With the rise of…

Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.

Imagine that hackers breached a small healthcare practice through “phishing”—sending a scam email and gaining access to sensitive patient…

Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach. Various stakeholders, including the industry, regulators, and patient rights groups,…

With its roots in compassion and humanity, the healthcare sector might seem an unlikely place for artificial intelligence (AI) to play a big role. Yet as we look deeper into the complex processes that build our medical systems, we uncover a multitude of ways that AI could revolutionize patient…

The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the…

This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across [their] total product life cycle…

In food processing, bulk-bag discharge systems are used to transfer food ingredients such as flour, sugar, and spices from bulk bags to mixing and blending equipment. However, when not designed or installed properly, bulk discharge systems can become a production bottleneck.

…

On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).

The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation…

There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.

CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning…

Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices…

When a patient comes into a clinic or hospital, healthcare practitioners have all the tools at their disposal to conduct thorough examinations. However, when they see a patient online, they may lack the necessary equipment to conduct the visit properly. One reason for this is that virtual care…

Here are just a few potential advantages of 3D drug printing—a new system for manufacturing drugs and treatments onsite at pharmacies, healthcare facilities, and other remote locations: chocolate-flavored pills for children who hate taking medicine; several drugs combined into one daily pill for…

If you’re a medtech professional who’s been working with the quality system regulation (QSR) in the United States, then you’re probably familiar with the three terms the U.S. Food and Drug Administration uses for record-keeping requirements: 1) device master record (DMR), a compilation of…

Look through even a few FDA warning letters and you’re likely to find violations related to change management.

For instance, a recent warning letter from the U.S. Food and Drug Administration cited a pharmaceutical manager for changing drug components without justification.…

Health connects each one of us to one another. No matter where we are in the world, who we are, or what we do, the state of our health is a key determinant in our quality of life. Simply put, it’s our most valuable asset.

Individual health crises can be disastrously grim, and if…

In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.

The FDA classifies medical devices by risk into three categories: Class I,…

An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.

It’s one of several factors motivating companies to switch to automated training management…

In the dynamic landscape of the life sciences industry, ensuring compliance with good manufacturing practices (GMP) is imperative to guarantee the safety, efficacy, and quality of pharmaceutical products.

One critical aspect of GMP is the analytical product quality review (APQR),…

The Center for Organ Recovery & Education (CORE), a 2019 Baldrige Award recipient, is a nonprofit organ procurement organization (OPO) in Pittsburgh with a federally designated service area encompassing a population of 5.5 million in western Pennsylvania, West Virginia, and one county in New…

Medical equipment is a necessary yet substantial investment for any health system. Making strategic decisions about these assets can be daunting in the face of shifting patient demand,  financial uncertainty, and fast-changing cybersecurity risks. 

Because clinical assets account…

The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.

FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all…

Michele Gelfand finds inspiration for new projects all around her: taking in the banter in a boardroom, speaking with taxi drivers when traveling, observing the interactions between physicians and nurses during an unexpected trip to the doctor. The idea for one of her most recent papers was…

Stain-resistant clothing, fast-food wrappers, and extreme weather gear such as certain jackets and pants—these products get many of their desirable features from a class of manufactured chemicals called per- and polyfluoroalkyl substances (PFAS). But there’s a major downside: Researchers have…

As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”

In the field of quality, internal audits are the equivalent of sunlight. Like spring cleaning, internal audits provide the opportunity to bring process issues into the open…

An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.

The MedTech space is huge, and even the standards that are meant to help, like ISO 13485:2016, cover a lot of ground.

So, if you’re part of the audit team in…

Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.

The FDA mandates that medical device companies, for example, designate a formal unit for…

In the ever-evolving life-sciences industry, market share is fiercely contested and companies must continuously optimize their operations to maintain their competitive edge.

Modern technologies and intelligence-driven solutions are revolutionizing how organizations work, empowering them…

At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there. And because the Qualio+ team combines over a century of collective quality and regulatory experience from within the life science…

Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.

The rise has more than doubled within three years of post-…

Today’s quality leaders in the life sciences industry have nearly impossible charters. Long-term trends and sudden black swan events in combination can hinder an organization’s ability to exert control over product quality. Globalization, labor shortages and strikes, outsourcing, just-in-time…

To provide food processors with insight into the industry’s current challenges and opportunities, Cablevey Conveyors, a global specialty conveyor manufacturer, and Automated Handling Solutions, a service-focused subsidiary of Cablevey, have released results from an annual proprietary survey…

There’s an old saying in regulated industries: If it isn’t documented, it didn’t happen.

In the past, maintaining fully compliant documentation meant handling a mountain of paper, which created extra work—and hidden risks—from a quality perspective.

Today, document management has…

Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good grasp of them makes the process less confusing.

Understanding ISO 14155:2020 is essential. It’s…

In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO 13485 for medical device quality management.…

If you’ve ever enjoyed the experience of an audit or inspection, then you know it’s about as much fun as having your wisdom teeth extracted. As painful as audits and inspections may be, they are necessary to bring needed medical products to market and monitor them to protect consumers and…

In the wake of the Covid-19 pandemic, medical device supply chains are one of the top priorities for health system leaders. Amid supply chain disruptions during the pandemic, hospitals scrambled to find enough devices to keep up with unprecedented demand. The global crisis revealed gaps in…

Getting blood test results can take anywhere from a day to a week, depending on what a test is targeting. The same goes for tests of water pollution and food contamination. And in most cases, the wait time has to do with time-consuming steps in sample processing and analysis.

Now, MIT…

Let’s start with a definition of Industry 4.0, keeping in mind that we’re rapidly approaching Industry 5.0. Industry 4.0 is an era marked by enhanced digitization and the increased connectivity of smart technologies. Where Industry 5.0 is more values-driven, it will require the technology of…

On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (…

Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S. Food and Drug Administration (FDA) inspections, particularly for the medical device industry. Issues can occur while…

Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).

A QMS contains everything…

Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.

FDA guidance also makes an explicit link…

Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country to country. This brings unavoidable technical complexity to daily tasks of quality and…

The levels of contaminants in our food supply are, generally, decreasing. That’s the good news.

But we still need to measure those contaminants and make sure our food is safe. And measuring tiny things (and big things) is what we do best here at NIST.

In our food safety program,…

Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done. And when you’re working in a regulated industry, processes tend to get more locked in because compliance is at stake.

Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance. When companies use a horizontal QMS that is not purpose-built for the life science industry, they must execute additional steps to…

I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No. 1, shoot me an email.) As you build medical devices, a well-defined CAPA program provides a…

As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices. From cardiac stents to simple dental tools used to correct teeth, the healthcare systems of the world have come to rely on ISO 13485 to provide critical support to…

In a highly regulated industry like medical technology, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing the correct result. The question is, which one should you use?

Verification and validation are two…

Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry. Healthcare providers that have embraced smart medical IoT solutions reduce costs, improve patient experience, and ensure preventive care.

The trend is not…

For owners and operators in the agricultural and food-processing industries, Jan. 1, 2022, was the deadline for completing a dust hazard analysis (DHA) for existing facilities in accordance with Chapter 7 of the National Fire Protection Association’s Standard 61 (2020) for the Prevention of…

Unpatched vulnerabilities remain a target of cyberattacks, and an ever-present risk for healthcare organizations. Medical devices pose an additional burden because patches are frequently unavailable for medical devices. So, dealing with the potential threat isn’t usually straightforward. The…

With the threat of contamination from harmful pathogens such as salmonella, listeria, and e. coli a continual concern, food processors are seeking to protect not only the public but also their companies’ bottom lines from the massive costs, reputational damage, and greater regulatory scrutiny…

In 2010 a medical device scandal in France set the stage for a new European Union medical device regulation that, according to most experts in the medical device community, may cause more damage than the problem it was intended to address. An unreasonable deadline, lack of notified bodies to…

Every company wants to succeed, but not all can say they meet the current requirements to do that. More than a focus on capital, business plans, or staff, a successful business in 2022 must operate digitally. Yet for the 45 percent of small and medium-sized businesses (SMBs) that still rely on…

Florida’s outbreak of listeria has so far led to at least one death, 22 hospitalizations, and an ice cream recall since January 2022. Humans get sick with listeria infections, called listeriosis, from eating soil-contaminated food, undercooked meat, or dairy products that are raw…

The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply chain and overwhelming market demand for shortened production times.

They are also being…

The use of membrane technology as a processing and separation method in the food industry is gaining wide application for demineralization, desalination, stabilization, separation, deacidification, purification, and reducing microbial load.

Perhaps the most obvious application for…

Ultra-low temperature freezers became popular due to the storage of Covid-19 vaccines, but they have been important components of laboratories for many years. There’s a lot, however, to think about—quality, productivity, maintenance, different types of technology, warranties, etc. And if you end…

Quality management is essential to the growth and performance of any organization. It’s a valuable resource in the effort to ensure that products and services satisfy the highest quality requirements and deliver positive customer results.

Pharmaceutical manufacturers must ensure that…

By now, it’s no secret that good clinical practice (GCP) guidelines used by FDA inspectors are expanding. These GCP guidelines are developed by the International Conference on Harmonization. The ICH last revised its GCP document, called ICH E6(R2), in 2016. It will be releasing a new version in…

The digital transformation of healthcare is under the influence of trending technologies, from IoT devices to AI algorithms. Some healthcare providers are just getting acquainted with innovations. Others (93%, according to Accenture) are already actively implementing and creating software…

Predictive and prescriptive insights driven by data analytics have risen to prominence as tools that can help research teams cut the time, complexity, and cost of clinical trials. At the same time, these insights can enhance the quality of a study and accelerate new drugs to market. But to…

On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international…

Whether it’s bananas, olives, potato salad, or cereal, many products are priced according to their weight. That weight is likely determined on a scale tested and certified by a specially trained state or local inspector. Weights and measures underpin approximately half of the United States gross…

It takes 10 to 15 years and around $1 billion to develop one successful drug. Despite these significant investments in time and money, 90 percent of drug candidates in clinical trials fail. Whether because they don’t adequately treat the condition they’re meant to target or the side effects are…

According to the CDC, approximately one out of six Americans are diagnosed with foodborne diseases each year. Out of this, about 128,000 are hospitalized, and as many as 3,000 lose their lives.

These sorry statistics show why food safety is paramount and why more effort should be put…

Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers. Problems with CAPA top the list of reasons for 483s and warning letters from the FDA year after year, and many companies struggle to identify when they should even initiate a CAPA.

When…

Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for…

The pandemic has seen an unprecedented global effort to accelerate the development of safe and effective vaccines as well as a rapid expansion of vaccine manufacturing capacity. However, challenges in further scaling up vaccine manufacturing capacity to meet higher-than-expected demand, and the…

The origin of SARS-CoV-2 remains a mystery. One theory is that the coronavirus that causes Covid-19 was transmitted from animals to humans—a fairly common occurrence. Another is that it came from a laboratory accident—a more infrequent circumstance.

Around the world,…

Believe it or not, the technology that brought you Bitcoin is beginning to make waves in the food manufacturing industry. This technology, called blockchain, is a digital ledger maintained across several computers, then linked through a peer-to-peer network. The system's design makes it…

Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges. The goal is to start up as soon as possible once the project is completed but also to achieve steady-state throughput as quickly as possible after the startup begins. This…

In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create…

T

he U.S. Food and Drug Administration (FDA) regularly inspects manufacturing facilities to ensure that drugs meet rigorous quality standards. These standards are vital to protect patients from drugs that are incorrectly dosed, contaminated, or ineffective.

But over the past…

To meet increasingly strict compliance standards, such as the Food Safety Modernization Act (FSMA) and Global Food Safety Initiative (GFSI), food processors now regularly use adenosine triphosphate (ATP) testing to monitor equipment surfaces for microbial growth. Add to this the need to minimize…

Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.

If there’s any “spoiler alert” to this…

Food manufacturers must carry out numerous specific processes to check that the foods they produce and distribute are safe for consumers. Analytical testing plays a vital role in meeting that goal. Here’s a look at how such examinations raise food quality and purchaser trust.

During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The Covid-19 pandemic required us to rework our business operations so that we could carry out our public health…

There are many important issues to be considered in the food industry, such as consumer tastes, environmental impact, and economic aspects, but the most important is food safety.

Although current food safety management system (FSMS) certification schemes around the world are highly…

Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.

Whether a laboratory develops its own…

During a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other products derived from cannabis. However, we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds,…

As someone who has helped companies in a wide variety of industries for the last 30 years solve many problems using risk-based thinking, I cannot think of an issue that I have worked on that is more important than preventing the spread of Covid-19. With three high-risk people in my home, I have…

Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s…

Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.

Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device…

About one in two U.S. adults has a musculoskeletal disorder, costing an estimated $213 billion each year in treatment and lost wages, according to a report from the United States Bone and Joint Initiative. Musculoskeletal disorders (MSD) are injuries and conditions to the bones, muscles, and…

Americans may be surprised to learn that many 21st-century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an…

Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention. Consequently, the FDA Food Safety Modernization Act (FSMA) is transforming the…

Given the death, suffering, social disruption and economic devastation caused by Covid-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.

But the U.S. Food and Drug Administration (FDA), charged with the task of evaluating…

Around the world, local agencies and institutions have scrambled to find personal protective equipment (PPE) to protect their essential employees from Covid-19. Not just healthcare workers, but also the men and women who to work to keep our cities and counties up and running, from emergency…

It’s easy to assume that something as simple as a mask wouldn’t pose much of a risk. Essentially, it’s just a covering that goes over your nose and mouth.

But masks are more than just stitched-together cloth. Medical-grade masks use multiple layers of nonwoven material, usually…

So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition.

An example of this is what one of my coaching clients experienced…

Even in the midst of the pandemic, product safety and quality remain critical. For many manufacturers, complex quality management systems and procedures stand in the way of agile responses and effective operational optimization. Cloud technology provides the means to dramatically simplify…

Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle,…

According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in occupational safety.

Companies conducting layered process audits (LPAs) can help get the United…

We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the same, and they continue to amass more and more data with each passing day. With the large amount…

Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore,…

The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the United States. With all of this growth, it is also apparent that many manufacturing corporations are…

As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and…

Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups.

Also, each…

Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.

…

According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every…

In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages. This was the third and largest verdict against Monsanto, now owned by German…

The food industry is evolving rapidly, with consumers demanding quality, authenticity, and transparency from food manufacturers. And they’re not just demanding it; they’re “voting with their dollars,” supporting companies that align with their personal beliefs. To keep up with consumer demand—…

On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive…

In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality across product development and manufacturing processes. This challenge is particularly evident in…

Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and…

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR…

Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the…

While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace external cloud networks. Merely a decade ago, in fact, an International Data Corp. survey showed…

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

…

Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the report from Kaiser Health News, “Since 2016, at least 1.1 million incidents have flowed into the…

Despite the life science industry’s infatuation with modernity and trend chasing, even its most forward-thinking organizations have struggled to fully digitize and integrate their operations.

Yet, while the industry lags behind most other sectors in implementing business-streamlining…

It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing…

For centuries, medical procedures, prescriptions, and other medical interventions have been based largely on experience—what is known about a set of symptoms. The doctor looks at those symptoms, tests you in various ways (blood tests, X-rays, MRIs), and interprets the results based on experience…

In 2013, thousands of consumers in the United Kingdom (UK) and Ireland bought, prepared—and ate—beef lasagna, hamburgers, and frozen dinners. What they didn’t know is what they were actually putting in their mouths.

Although a burger is only required by law in that region to contain 47-…

Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world. It only takes one incident to…

Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer. What’s the cost of that poor quality…

Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science…

Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?

1988: Food and Drug Administration Act
Officially establishes the FDA as an agency of the Department of Health and…

As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.

The goal of any honest pharmaceutical company is…

Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…

We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-…

One of our favorite things on our show is to welcome guests, either via Skype or live in the studio. And this week, we were joined by three of our great partners. Here’s a closer look:

Interview: Nicole Radziwill of Intelex

Radziwill is quality manager and data scientist along with…

In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.

“GE’s Lessons Won’t Determine Whether You Succeed or Fail”

Does the success or failure of GE’s CEO really matter that much when it…

BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life…

These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest…

The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…

The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political…

One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products…

Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies…

An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used internationally. It follows other…

During the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These therapies are demonstrating response rates large in magnitude or response durations prolonged in early…

‘Culture” is one of those business-speak words that’s used a lot, but for a good reason—having the right one is the key to unlocking your company’s quality potential. On the other hand, nothing will overcome a poor culture. Do you know which you have? We explored these issues during the Aug. 10…

During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods.

A cosmetic eyelash and eyebrow dye called Lash Lure, for example, which promised women that it would help them “radiate personality,” in…

The medical marijuana industry is being heralded as the new frontier in the life sciences, thanks to the potential of cannabis-derived products in treating ailments that range from chemotherapy-induced nausea to epilepsy and neuropathic pain. If you’re a startup in the industry, what does this…

The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our stature as the global “gold standard” in drug regulation. Maintaining that standard requires us…

The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies.

Consider Second…

Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary conditions as the two most common…

In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.

For instance, we announced our intention to propose an alternate approach to the…

Regulatory experts from around the world, including the Food and Drug Administration (FDA), gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or…

QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look:

“What Really Causes Workplace Stress”

A multidisciplinary team of researchers…

The food labeling craze coupled with banner headlines about the dangers of gluten, genetically modified organisms (GMOs), and hormones are leading to increasingly absurd results.

For example, you can now buy “premium” water that’s not only free of GMOs and gluten but certified…

If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.

When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the…

Our Oct. 27, 2017, episode of QDL looked at Ford, autonomous cars, and changes to FDA compassionate use rules.

“Ford Plans $14B in Cost Cuts as Part of New CEO’s Strategy”

Ford Motor Co’'s new CEO plans to cut $14 billion in costs, drop some car models, and focus…

The FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We also offer expanded access programs that provide…

We cover a wide range of topics on QDL most weeks, but our latest episode, from Friday, Oct. 20, 2017, provided a steady drumbeat of technological detail. Here’s what we chatted about:

“Energy Harvested from Evaporation Could Power Much of U.S., Says Study”

…

How confident are you when it comes to design validation? Does this always involve clinical evaluation, or not? We’ve found that, like many other terms in medical device development, the two can end up getting confused. When do you use one or the other?

There tends to be a lack…

If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26, 2017, security advisory from the company.

The Industrial Control System Cyber Emergency…

We’re at a moment of extraordinary opportunity to improve public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing consumers with a broader selection of foods that can improve peoples’ diets and products that can…

When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not have been an option for me at that time.

Yet, it is…

Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.

“Climbing Stairs Just Got Easier With Energy-Recycling Steps”

These stairs actually help you go up.

“The Curious Case…

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.

An FDA investigation was conducted from January to…

It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies…

On Jan. 1, 2017, Philadelphia became one of the first U.S. cities to pass a tax ($0.15 per oz) on sugary drinks, including artificially sweetened beverages, such as diet soda. In California, San Francisco, Albany, Berkeley, and Oakland have joined Philadelphia in this initiative, as well…

The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).

Responding to the Center for Devices and Radiological…

The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.

The CDRH continues to put a premium on quality when it…

Sponsored Content

Founded in 1927 to produce aluminum splints—cutting edge at the time—Zimmer Biomet is a medical device company commanding second place in the entire world’s overall orthopedic market share. The organization’s stated purpose is to “…

People have touted the potential of big data and computation in medicine for what feels like decades, promising more effective and personalized treatments, new research discoveries, and smarter clinical predictions. But only recently have these technologies made it to the clinic, where…

The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful, computer-based system that separates critical bits of information from vast streams of…

It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.

We may think of the pharmaceutical industry in terms of giant corporations, but the fact…

If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device developer, and I’ve noticed that this area tends to be rife with misconceptions, confusion, and…

The U.S. Food and Drug Administration’s (FDA) “History Vault” contains more than 10,000 artifacts that provide a journey through U.S. history and document the critical role played by one of the nation’s oldest public health agencies during its mission to promote and protect American…

Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st…

If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe…

About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The report findings were derived from focus group studies with reviewers from the FDA’s different…

For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from…

The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don’t bet on it.

In the most…

Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s…

During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the…

It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—…

When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at risk” and “risk-based” are used more and more, but what do they really mean? And why should…

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18,…

The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and…

Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.

All too often, however, design controls and risk management are viewed…

Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.

In fiscal year 2015, there were more than 34 million…

In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply these constructs as we go about building…

They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in their formal greetings. They are the most expensively researched neologisms in use around the…

The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major parts of the FDA quality system that…

Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy…

I

n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render…

Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the center as the preeminent regulatory organization for biologics. One way CBER is achieving this is through the work of the Office of Compliance and Biologics Quality (OCBQ) and the Office of…

The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages.

When…

The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member…

In this third and final article reflecting on the FDA’s work to protect and promote public health during 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation. In part one I shared the FDA’s 2015 accomplishments in medical product…

In my first look back on the FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make available safe, effective, and innovative products. Because the FDA’s responsibility covers the entire life cycle of products, in the second…

Since March 2015 it’s been my pleasure to serve as the Food and Drug Administration’s (FDA) Acting Commissioner. The FDA has broad responsibilities, and I’d like to share some important accomplishments during 2015.

Tasked with overseeing products that account for about 20…

Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and personal devices comprise an immense new set of sources for data about…

Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and…

As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter…

Has your organization secured all its electronic healthcare records (EHR)? If not, don’t wait to put the proper policies and procedures in place. If you’ve already secured your EHR, then make sure that you’re ready for an audit by the Office for Civil Rights (OCR).

I recently…

I read trade publications that cover everything from banking to biotech, looking for interesting perspectives on data analysis and statistics, especially where they pertain to quality improvement.

Recently I read a great blog post by Tony Taylor, an analytical chemist with a…

The FDA just issued a Safety Communication on the cybersecurity vulnerabilities of the Hospira Symbiq Infusion System, which is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population. The pump is mostly used in hospitals or…

Just when we’d all decided Washington lawmakers won’t accomplish much beyond enjoying their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on Capitol Hill, it turns out they might actually unite to accomplish something pretty big…

The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over.

This is troubling. My first question: How are IRBs going to assure that clinical investigators will abide by requisite 21 code…

Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with Apple’s new ResearchKit tool, which promises…

When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet FDA requirements for your design…

If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements…

Nestlé USA has officially announced its plans to replace the artificial flavors and colors in its chocolate candy products with natural ingredients. This decision will affect more than 250 chocolate bars across 10 brands. The first three modified candy bars—Baby Ruth, Butterfinger, and…

Sometimes it’s nice to be told what the U.S. Food and Drug Administration (FDA) isn’t going to do. The agency issued a guidance last month that should make anyone building or working with a medical device data system (MDDS) happy and relieved. Can you hear the collective sigh?

…

Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of Giza took about 20 years to construct, according to ancient historians, but it must be…

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s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not…

If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting.

Although not much has changed in…

Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be even more time-consuming when individual regulatory authorities require an independent…

The landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the Food and Drug Administration (FDA) unveiled four proposed amendments that will likely make a tough law even tougher.

The FSMA, signed into law in January…

Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges for manufacturers. It’s important to understand how the FDA uses IEC 62304, an international…

In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare…

Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.

As the agency notes, “Failure to adequately consider potentially hazardous situations…

The U.S. Food and Drug Administration (FDA) won’t enforce compliance with regulatory controls that apply to medical device data systems (MDDS) and medical image communications devices, recognizing the “low risk” they pose to patient safety and the importance they play in advancing…

Most of us, at one point or another, have been faced with making a decision to purchase a software application. Whether a simple application to manage your schedule or a more complex quality management software, the challenge is the same: How do you decide if a software application meets…

The World Health Assembly is the decision-making body of the World Health Organization (WHO), attended every year by leading government health officials from its 194 member nations. Recently, I was pleased to participate as a member of the U.S. delegation in the 67th meeting of this…

In recent years, there have been important advances to ensure that therapies for serious conditions are approved and available to patients as soon as sufficient data can show that the therapies’ benefits outweigh their risks. Despite the progress, there is much more work to be done. Many…

Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.

In Annex 1 of the “Medical Device Directive 93/42/EEC—Essential…

Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.

Food and beverage manufacturers have seen a considerable number of changes over the last decade. Mergers and acquisitions have expanded the footprint of many food…

Have you sometimes wondered if that “wild caught” salmon actually came from an aqua farm? Or if the “U.S. catfish” in the display case might have been born and raised in Vietnam? Is that “red snapper” actually red snapper and worth the premium price?

Scientists at the U.S. Food…

Some of the shortest descriptions in the Food and Drug Administration's (FDA) CFR 21 Part 820—“Quality System Regulation” are found in Section 820.30 and Section 820.40, totaling about a page of information about design and document controls. However short, these two sections outline…

It’s a growing trend in these United States: paying extra for conveniences such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine, pay-for express lanes.

Where I live in the Washington, D.C. area, the new express road…

A new Food and Drug Administration (FDA) draft guidance, “Medical Device Development Tools—Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff,” outlines a voluntary process for qualification of medical device development tools (MDDT).

The…

Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately…

The Food and Drug Administration’s (FDA) “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by Congress. More than half of the operating funds will be earmarked for food work.

International food inspections will…

My colleagues and I at LNS Research have spoken to numerous companies during the past several years that have done an admirable job of building compliance into production processes. However, there are still many companies, particularly in the manufacturing sector, that struggle to meet…

According to the quarterly ExpertRECALL Index, 48 percent of all medical device recalls reported during the second quarter of 2013 had both U.S. and international components. In addition, the number of device recalls increased 30 percent from the last quarter, resulting in the highest…

For medical devices, the term “interoperability” refers to the ability of various devices to interact, and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments such as a web cam or mouse…

It’s a small world. Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year.

That’s why it’s so…

In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high: $1…

T

ake a moment to consider some of the foods we find at the supermarket: eggs, tomatoes, coffee — maybe even chocolate chip peppermint brownie ice cream. Now, try to imagine all the steps and processes that the food went through to get all the way to those shelves.

Although the…

Turns out that some paranoid people have a reason to, well, be paranoid. Researchers from the London Business School issued a report last year finding that many people at work who thought they were being talked about were probably right.

Maybe some in the medical device…

The first production Model T auto in 1908 ushered in a new era of transportation by shrinking dramatically the time it took for people to move from place to place. Like the Model T, communication technologies such as email, mobile phones, and the Internet are dramatically shrinking the…

A Jan. 11, 2013, email sent by Michael Fauntleroy, program manager for the Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG), the agencywide solution for accepting electronic regulatory submissions, warns those using the WebTrader for electronic submissions to delete their…

Last December, Sunland Inc. entered into a court-ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows the Food and Drug Administration’s (FDA) suspension of Sunland’s food facility registration in November 2012. The…

Every year, millions of products regulated by the Food and Drug Administration (FDA) flood into the United States from 150 countries. Ensuring these products are safe and effective can be daunting task. It was heartening for me to sign two cooperative arrangements with some of our international…

Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union.

They apparently aren’t happy that the Food and Drug Administration (FDA)…

During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka 510(k), sooner than expected. This will be due to a six-month pilot program called Triage, launched…

While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over dissenting science or how its own advisory boards vote on medical device classification…

Banner Medical is committed to an ambitious approach to quality assurance, one developed specifically for the evolving, critical needs of the medical device industry. The company believes this investment achieves multiple payoffs—in relationship-building with customers, in risk…

Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier regulation in 2012, and that will only increase if President Obama is reelected in November.…

Budget-conscious firms that do business in China and elsewhere outside the United States may not like what they find in the Food and Drug Administration’s (FDA) request in the Budget of the United States Government, Fiscal Year 2013.

While it is one of the few agencies that could see its…

It’s actually bigger than a battle over a popular condiment, according to some folks who oppose what they say is the Food and Drug Administration (FDA) overplaying its regulatory hand.

We’re not going to settle this controversy here, but some experts suggest you may be able to sprinkle a…

(ASQ: Milwaukee, WI) -- The results of ASQ’s 25th annual Salary Survey show strong average salaries for quality professionals in 2011 and fewer lay-offs as companies continue to see the value of quality and its positive impact on an organization.

The survey results also show that…

Under pressure from all sides, the beleaguered Food and Drug Administration (FDA) keeps announcing new reorganization initiatives, name changes, and all sorts of stuff that would be funny if it was scripted by the same team handling Steve Carell’s departure from The Office and the ushering…

The Food and Drug Administration’s (FDA) international program has logged nearly 75,000 hits to its web pages on the new food safety law, as foreign companies that export food to the United States scramble to learn how the law affects them.

“A lot of our foreign offices are being…

What products will be affected by the Food and Drug Administration’s (FDA) quality by design (QbD) stipulation, as outlined in its report, “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”?

It will apply to new marketing authorization applications, new drug…

As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?”

The United States has had its own headline-grabbing outbreaks from contaminated vegetables—such as lettuce in 2010,…

Well, this is getting interesting. For the past several months, we’ve had relatively partisan folks on each side of the medical device industry vs. the Food and Drug Administration (FDA) debate saying either the 510(k) premarket notification  process wasn’t doing so badly (the FDA), or that it…

Just when you think that the Food and Drug Administration (FDA) has to stick to the script by quoting chapter and verse of current Good Manufacturing Practices (CGMPs), it gets very progressive and offers straight talk about corporate commitment and leadership.

I have reported before…

Keith Greenaway, vice president of ACLASS, a brand of ANSI-ASQ National Accreditation Board that provides accreditation, gave a brief talk titled “Focus on Inspections and Compliance” at the FDA Food Safety Modernization Act public meeting held on June 6, 2011. His prepared remarks follow:…

I don’t know how I missed this gem, but on March 24, 2011, the Food and Drug Administration (FDA) sent a Warning Letter to Jonathan’s Sprouts Inc. informing the company that it was (among other things) marketing its organic mung bean, alfalfa, and broccoli sprouts as drugs. The FDA said it…

Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it?” You can be sure these firms had several dry runs and dress rehearsals to hone their material…

How safe is our food? It is a question asked all over the world on a daily basis as food-scare stories fill the media and governments act to calm consumer fears. There is a real and tangible concern among the public; an IBM consumer confidence survey in 2009 found that 80 percent of those…

“Under-promise, over-deliver” is a phrase taught to me many years ago by my friend and colleague, PQ Systems’ owner Michael J. Cleary. It may have always been true. It may always be true. It is certainly true today.

I am in the middle of a sabbatical that requires me to buy and learn to…

Companies aren’t perfect, and neither are the people who work for them. Since this is a fact rather than a judgment, it’s reasonable to expect errors in manufacturing and process management. When an audited company continues to show a flawless record for, say, a food-safety audit, chances are it…

Read this. It won’t be a waste of time.

Time gets lost. People kill time. Time flies. It gets wasted. Time weighs heavy on our hands. We spend time. Time passes. It drags on or it hurries by. Those behind bars are said to be doing time. Sometimes, we have no time left; we’re out of…

Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones…

Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones…

If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S. Food and Drug Administration…

It turns out that I am not the only one who has noticed that food regulation is sometimes a little, well, silly. The federal government recently “identified a mother lode of government waste and duplication” and decided that getting rid of it “could potentially save billions of tax dollars…

The recent brouhaha involving a class-action suit against Taco Bell alleging that their beef filling is more filling than beef really got me thinking, but not about what’s in the tacos. Instead, it got me thinking about quality control, quality assurance, and particularly about customer…

In business there’s a saying: Time is money. The more time it takes for something to get done, the more money is wasted. Companies that can figure out a way to compress the time it takes for something to happen can realize significant cost savings and also get their products into the market…

People often ask me how best to prepare for a Food and Drug Administration (FDA) inspection when you know that you have problems. My first response is that they have already taken the first step: acknowledging that there are problems. Believe me; that is a huge first step. Just like Alcoholics…

Digital pen technology is an efficient data management solution that offers better operational visibility, enabling manufacturers to react quickly to the production process and respond to issues via immediate data access. Hyla Soft’s FactoryScribe is a lightweight web application built around…

A new year always brings new hope, new plans, and new perspectives. While looking ahead is the most direct route to progress, looking back is essential to understanding the present. After all, the past creates the consequences that will shape the future.

With this in mind, the…

Ken Appel is the manager of regulated industries for Veriteq.

In part 1 of this article, we discussed the pros and cons of various systems for stand-alone monitoring instruments (e.g., chart recorders and data loggers) and wired networks, with and without power over Ethernet (POE). In…

Ken Appel is the manager of regulated industries for Veriteq.

T

he U.S. Food and Drug Administration (FDA) and its European Union counterparts recently agreed to cooperate on pharmaceutical plant inspections to enable stepped-up enforcement of safety guidelines. These…

Food safety standards are becoming increasingly stringent. Although government legislation has long been implemented, your customers may be driving an even higher standard of food safety through the Global Food Safety Initiative (GFSI) or Safe Quality Food (SQF) Institute, which require third-…

My definition of “specification” is rather simple: It’s a promise.

Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is…

In Part I, Part II, and Part III of this compliance series, I have described the benefits of using a closed-loop process for managing regulatory compliance (illustrated in figure 1).

Readers of…

On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and…

Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485. Manufacturers…

For quite some time, polls have indicated that public approval for Congress remains at an all-time low. Congressional gridlock is difficult to watch for U.S. citizens who care about any issue and how our legislative process resolves the problems of our time—no matter what their party…

The compliance department’s primary function is to ensure that the company complies with all applicable regulations, rules, and laws. Regardless of the industry—life science, energy and utilities, or financial services—this is a universal mandate.

As someone who serves customers…

In the classic Aesop fable, “The Fox and the Grapes,” a fox desires some grapes hanging high overhead. When he is unable to come up with a way to reach them, he convinces himself that the grapes are probably sour and therefore not desirable anyway. “Sour grapes” has become an idiomatic…

With the morning mist still on the Hudson River and the sun just kissing the cliff tops of the New Jersey Palisade, Aaron Burr, vice president of the United States, shot and killed former Secretary of the Treasury Alexander Hamilton. Political opponents for years, the duelists faced each other…

In recent years, there have been published reports of an increase in Food and Drug Administration (FDA) inspectional observations associated with training deficiencies. Specifically, these inspectional observations have focused on training related to the quality system requirement that…

Where does the U.S. Food and Drug Administration (FDA) stand on good manufacturing practices (GMP), the set of regulations that govern manufacture and testing of medical devices and other medical products like pharmaceuticals, diagnostics, and food? And what of the universal device…

After years of focusing on the pharmaceutical industry and establishing better controls for reviewing the safety and efficacy of pharmaceutical products prior to approval, the Food and Drug Administration (FDA) is now directing its attention to the medical device industry.

On Feb. 18…

The molecular diagnostics industry is a relatively new territory that offers much promise for early disease detection and personalized patient care. When analyzing samples at the molecular level, there are serious consequences for errors, and tests must be highly accurate and precise. For…

The rapid pace of technological advancement in the last decade has introduced both significant benefits as well as significant challenges to medical device makers. Companies these days are faced with demands of bringing products to market faster and faster, not only to meet sales and…

The FDA’s Center for Devices and Radiological Health (CDRH) posted a notice of draft guidance that will require all medical device adverse-event reports to be submitted electronically. While the process of electronic submission of data is a more efficient and traceable means for reporting, it…

In this case study of reverse engineering and rapid prototyping we will look at a company that developed an initial prototype of an anti-snoring device based on many years of research in the field of dentistry. The company’s main dental advisor is a pioneering dentist in the research and…

Radio frequency identification (RFID) systems are widely used for applications that include inventory management, package tracking, toll collection, passport identification, and airport luggage security. More recently, these systems have found their way into medical environments to track…

Resistance to the National Animal Identification Scheme (NAIS) has been strong. This six-year-old USDA policy initiative to reduce the catastrophic effects to the livestock and meat industry from a major animal disease outbreak has received so much negative reaction from so many and now…

Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international standards for quality management systems (QMS)…

A $1 billion annual budget may sound ample, but a few years ago, the costs of services ranging from law enforcement to cleaning county buildings had squeezed the government of Erie County, New York, to its limit. Residents faced a painful choice: raise taxes or slash services. But Chris Collins…

Twitter is the latest new thing. Want to follow John McCain or Al Gore throughout their day? Easy. Just sign up to receive their tweets. While their tweets may provide insights, or just entertainment (Ashton Kutcher and 50 Cent also tweet), does Twitter have value for business management…

When I first got into quality, I really hated verifying the effectiveness of actions taken to correct a problem. After all, I was young and inexperienced. All of the people whose actions I was verifying were older, wiser, and more experienced than I was. Who was I to say that their actions were…

It’s no secret to anyone, anywhere, that we’re experiencing a global business challenge, especially in manufacturing.

One could argue that for too long, manufacturers in the United States have been complacent and indifferent to signs of market change, steadily losing market share to…

Geoff Bilau, senior writer for the International Association for Plumbing and Mechanical Officials (IAPMO) Group, was awarded first place for his paper by the American National Standards Institute (ANSI) for describing the importants of quality standards and accreditation.
--Editor…

I've been auditing to ISO 9001 since 1992. A part of my auditing philosophy has been to add value to the audited organizations by suggesting opportunities for improvement. Following, I will describe the most effective “value adds.”

Look at ISO 9001:2000 subclause…

The Food and Drug Administration (FDA) has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug, and food recalls.

Off the record, current, and…

Lysosomal storage disorders may not sound as dire as diseases such as cancer or Alzheimer’s, but to the people that suffer from them, life can be a nightmare. In fact, three of the primary disorders in this category—Gaucher’s Disease, Fabry Disease, and Pompe Disease—aren’t only characterized…

Internal auditing, when effectively implemented, can arguably be considered the most important tool in the quality system tool box. It’s the primary method for continuously monitoring a company's quality management system (QMS). In fact, the feedback from internal auditing is critical to the…

Liquid delivery is a common laboratory process and this critical function is often overlooked. As a result, routine research and test results can be in error based on a simple misunderstanding or misapplication of liquid delivery instruments. This article focuses on defining and exploring…

When regulatory compliance and risk management come to mind, they usually evoke feelings of fear, uncertainty, and doubt as to how well an organization is prepared for government scrutiny or any worst-case business scenario. Questions arise, such as: Have we developed the proper procedures to…

Alan Kent, president and CEO of Meadows Regional Medical Center in Vidalia, Ga., was a champion for implementing lean principles in the hospital’s emergency department.

Photo by Gary Meek

From an antacid to a new cancer treatment, every drug must be proven safe and effective in controlled clinical trials before the U.S. Food and Drug Administration (FDA) allows it to be sold in the United States.

When federal law first required controlled clinical trials in 1962, most…

Pharmaceutical processes typically take place on the scale of gallons or liters, even tens of thousands of liters. So why would anyone worry about one little microliter? Because in some situations, deviations as small as one microliter can mean the difference between success and failure.…

The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management…

In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (CGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling,…

In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (cGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging,…

In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (CGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging,…

For companies doing business in regulated environments, the benefits of implementing software systems are abundant. Improved product safety, higher quality, enhanced efficiency, and increased probability of maintaining regulatory compliance are just a sample of the numerous benefits…

From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action (CAPA) is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change…

The advantages to pharmaceutical companies of using electronic solutions to modernize their paper-based or partially electronic processes are enormous. Automation speeds up and connects all interrelated processes (corrective and preventive actions, customer complaints, audits, deviation…

In today’s quality management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization. Whether it’s tracking incoming customer complaints, identifying nonconforming materials from production, or using corrective and preventive…

Research reported recently in the journal Advanced Materials describes a potentially promising strategy for encouraging the regeneration of damaged central nervous system cells known as neurons.The technique would use a biodegradable polymer containing a chemical group that mimics the…

Tushar Sathe holds a vial of dual-function beads embedded with iron oxide and 600 nanometer emission quantum dots, while Shuming Nie looks on. The other vials contain beads embedded with quantum dots that emit light at other wavelengths.

photo by…

For people with impaired mobility and reduced ability to sense injury, the risk is high for pressure ulcers that can develop when they sit or recline in one position too long or wear a poorly-fitted prostheses for an extended period.

Clinical data collection helps…

This figure shows the 3-dimensional dose distribution of the prostate upon completion of implanted seeds. Based on patient tests, Lee’s inverse planning system uses 15% fewer seeds.

Photo by Eva Lee

A California medical…

CardioMEMS engineer Michael Fonseca uses a laser to separate pressure sensors in the company’s clean room facility in the ATDC Biosciences Center located at Georgia Tech’s Environmental Science and Technology Building.

Photo by Gary Meek…

Georgia Tech student Ashley Palmer, Ph.D., conducted experiments to validate a new cartilage-imaging technique developed by associate professors Marc Levenston and Robert Guldberg in the Georgia Tech School of Mechanical Engineering. On the…

Despite the best efforts of pharmaceutical manufacturers, drug labeling is one of the greatest challenges in clinical trials, involving a complex, time-consuming process to meet strict regulatory requirements and obtain wide-ranging approvals from individual countries. That labels…

Researchers Mark Prausnitz and Robyn Schlicher use a confocal microscope to study cells whose membranes have been opened by the application of ultrasound.

Georgia Tech Photo: Gary Meek

Researchers have…

An ABC News/Washington Post survey in 2003 found that for the first time, 54 percent of Americans were dissatisfied with the overall quality of health care in the United States.

Research engineer Phil Santangelo works in professor Gang Bao’s cell culture facility in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University in Atlanta.

Photo courtesy of: Phil…

Georgia Tech professor Zhong Lin Wang holds a sample nanowire array that can be used to power nanometer scale devices.

Georgia Tech Photo: Gary Meek

Researchers have developed a new technique for powering…

In our increasingly wireless world, the air is chock-full of electromagnetic signals carrying data from one place to another. Yet, while new wireless technologies advance our options in security, commerce and entertainment, they also produce interference that may cause problems for…

Georgia Tech postdoctoral fellow Jean-Francois Masson holds a microelectrode modified with a biosensing layer capable of measuring adenosine triphosphate (ATP), a chemical involved in energy transport in humans. It’s of interest to medical…

A newly developed family of biodegradable polymers has shown potential for use in intracellular delivery and sustained release of therapeutic drugs to the acidic environments of tumors, inflammatory tissues and intracellular vesicles that hold foreign matter.

These polymers…

Although conventional homogenization has served the needs of the dairy industry and other industries for more than a century, the producers of pharmaceutical, personal care, chemical and food products are increasingly turning to high-shear fluid processing when highly precise processing is…

The Dutch public health care system is being transformed in various ways. With an increasing focus on efficiency and consumer driven care, health institutions in The Netherlands are forced to critically evaluate their actions and processes. With recent political developments creating a more…

Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should…

If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens…

If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens…

More than a decade ago, Osteoimplant Technology Inc. provided the orthopedic prosthesis for a complete hip replacement for Mikhail Lavrovsky, one of the most famous lead dancers with the Bolshoi Ballet. He was able to dance with the replacement and continued to make appearances around the world…