GMP Tips - TR Signs Landmark Law 100 Years Ago Today - June 30, 2006

A hundred years ago, on June 30, 1906, President Theodore Roosevelt signed the Pure Food and Drugs Act, establishing the nation’s very first regulatory agency. With a stroke of his pen he expanded the reach of the federal government and planted the enduring concept of a nonpolitical, science-based agency, today known as the FDA, dedicated to protecting the public from commercial predation. But the law generated bitter controversy that continues to this day.

Theodore Roosevelt knew firsthand about seriously bad food. During the Spanish-American War in 1898 he asked one of his Rough Riders why he was throwing away his canned meat. The soldier said he didn’t like it. "Eat it and be a man," Roosevelt ordered. The fellow did so, and promptly vomited. Roosevelt examined the slimy, stringy ration and instantly understood why.

Read a fascinating article published in American Heritage Magazine on June 29, 2006
How Theodore Roosevelt Made Your Dinner Safe to Eat
Go to www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles

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GMP Tips - Validation and Three Runs - June 27, 2006

We are often asked about process validation and whether FDA requires three consecutive successful runs or batches. Three consecutive successful runs is the “Usual and Customary” practice in industry. The only written reference from FDA we know of comes from FDA's Human Drug CGMP Notes in 1999.

You can read this reference at www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources. (If you know of other written references from FDA, please let us know at info@GMPTrainingSystems.com and we'll pass that along in a future post.)

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Audio seminar - Understanding FDA's New Medical Device Innovation Initiative conducted by David Dills.
June 29 11:00 am EDT
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Audio seminar - Environmental Monitoring: The True Reasons - How to Develop and Implement an Effective Environmental Monitoring Program conducted by Gamal Amer, Ph.D.
July 13 11:00 am EDT
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GMP Boot Camp - The Fundamentals of GMP and QSR
July 19 - 20, Orlando
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GMP Tips - New Guidance Document - June 20, 2006

On June 15, FDA issued an update to the Inspection of Medical Device Manufacturers guidance document.

The compliance program outlined in this guidance document encompasses five regulations for inspecting medical device firms, including CFR21 - Part 820, the Quality System Regulation for Medical Devices. Under the Quality System regulation, manufacturers are expected to control their devices from design stage through post-market surveillance. The Master Device Reprting, Tracking, and Corrections and Removals regulations involve activities with which manufacturers and importers are required to comply after the devices are distributed. This compliance program provides specific guidance for each of these regulations.

Read a copy of this new guidance document at
www.gmptrainingsystems.com/asp/resources.asp
Click on Medical Devices.

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GMP Tips – Protecting America’s Health - June 12, 2006

Recently David Markovitz, Founder and President of GMP Training Systems, Inc. spoke at a major industry conference on the Evolution of Food and Drug Law: From the 19th Century to the 21st Century. He did this in his unique method of bringing Teddy Roosevelt Back to Life. At the same conference Philip Hilts, author of Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation, was also speaking and sharing his vast knowledge of the history of the FDA. At a dinner before the conference David and Philip had the opportunity to compare notes.

Afterwards we interviewed David about his meeting with Mr. Hilts and here’s what he said. "Philip’s book should be in every GMP Trainer’s library. His thorough research helps anyone working in the FDA regulated industries gain a better understanding of WHY we have the regulations we do. This can only help people understand their important mission when they take on employment in a company focused on saving lives and/or improving the quality of life."

Read a review of this book at http://www.gmptrainingsystems.com/asp/resources.asp
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Centennial of The Jungle

This month marks the centennial of the landmark book, The Jungle by Upton Sinclair. The publication of this book, more than any other event, led to the first federal legislation regulating the food and drug industry - the Pure Food and Drugs Act.

Go to www.gmptrainingsystems.com/asp/resources.asp and click on Timely Resource Articles to read a fascinating article just published about the some of the intricacies that led to this legislation.

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David Markovitz, President and Founder of GMP Training Systems, Inc. has a unique method for teaching the history of the FDA regulations. He brings Teddy Roosevelt Back to Life.

Go to www.gmptrainingsystems.com/asp/evolution.asp to learn more about how this presentation can energize your GMP training efforts.