Rob Matheson’s picture

By: Rob Matheson

Liquid-liquid separation and chemical extraction are key processes in drug manufacturing and many other industries, including oil and gas, fragrances, food, wastewater filtration, and biotechnology.

Three years ago, MIT spinout Zaiput Flow Technologies launched a novel continuous-flow liquid-liquid separator that makes those processes faster, easier, and more efficient. Today, nine pharmaceutical giants and a growing number of academic labs and small companies use the separator.

Eric Cooper’s picture

By: Eric Cooper

You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house you end up with is going to be what you want? Documenting your requirements should be obvious, right?

Mike Richman’s picture

By: Mike Richman

During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at work, and inspected some interesting stereo microscopes from Vision Engineering. Here’s a closer look at our show:

Multiple Authors
By: Jenna Gallegos, Jean Peccoud

Biology is becoming increasingly digitized. Researchers use computers to analyze DNA, operate lab equipment and store genetic information. But new capabilities also mean new risks, and biologists remain largely unaware of the potential vulnerabilities that come with digitizing biotechnology.

The emerging field of cyberbiosecurity explores the whole new category of risks that come with the increased use of computers in the life sciences.

Multiple Authors
By: Lou Valdez, Dara Corrigan, Peter Stein

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 falsified medical products.

Patrick Horine’s picture

By: Patrick Horine

Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly after being discharged; readmissions also hurt hospital bottom lines.

Readmissions cost hospitals $41.3 billion during the first 11 months of 2011, according to data from the Agency for Healthcare Research and Quality (AHRQ).

Mike Richman’s picture

By: Mike Richman

During last Friday’s episode of QDL, we examined the potential of quality thinking to improve outcomes for people’s health, manufacturing, and workplace efficiency. Let’s take a look:

The QA Pharm’s picture

By: The QA Pharm

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 procedure.

The responsibility of quality assurance is to ensure that an effective quality management system (QMS) is put in place procedurally, is in use behaviorally, and is in control measurably.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest


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”

Scott Gottlieb’s picture

By: Scott Gottlieb

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 investigational drugs and devices to patients with serious conditions (generally prior to product approval) when there is no therapeutic alternative.

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