FDA Compliance Features

Geoff Bilau's picture
Geoff Bilau
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 (...
James Odom's picture
James Odom
Charles Kettering, the famous inventor, once said: “A problem well stated is a problem half solved.” This implies that a good portion of problem solving should be devoted to a thorough understanding...
Sandford Liebesman's picture
Sandford Liebesman
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...
Tamar June's picture
Tamar June
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...
Anonymous's picture
Paul Richards
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...
Richard Strouse's picture
Richard Strouse
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...
George Rodrigues's picture
George Rodrigues
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...
Rory Granros's picture
Rory Granros
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...
Nancy Fullbright's picture
Nancy Fullbright
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...
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Linda Bren
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...
George Rodrigues's picture
George Rodrigues
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,...
James Jardine's picture
James Jardine
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...
James Jardine's picture
James Jardine
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...
Anonymous's picture
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...
Sharon Phillips's picture
Sharon Phillips
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...
Sharon Phillips's picture
Sharon Phillips
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...
David Ade's picture
David Ade
For companies doing business in regulated environments, the benefits of implementing software systems are abundant. Improved product safety, higher quality, enhanced efficiency, and increased...
Ken Peterson's picture
Ken Peterson
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...
MasterControl Inc.'s picture
MasterControl Inc.
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...
Tim Lozier's picture
Tim Lozier
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...