FDA Website Gets New Look - Mar 24, 2008

FDA has redesigned their website - www.FDA.gov.

Take a look and familiarize yourself with the new layout so that when you need something you'll already have a feel for the organization of the site.

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Warning Letters due to Inadequate Response to FDA 483s Rising - Mar 17, 2008

The number of Warning Letters issued because of an Inadequate Response to a FDA 483 continues to grow. One interesting Warning Letter, issued recently to Vintage Pharmaceuticals, LLC, points out the importance of good recordkeeping.

Read this letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Tip
Use Warning Letters like this one in your GMP training sessions to reinforce the importance of following cGMP as well as the requirement to follow procedures and document what is done when it's done.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1373 clients since 1996

April 16 - 17 Anaheim, CA
Fundamentals of GMP Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
June 25 - 26 Anaheim, CA
GMPs for Dietary Supplements Boot Camp

GMP Training System Now Available in Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

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FDA at a Turning Point according to FDA Commissioner - Mar 10, 2008

On February 29, 2008, FDA Commissioner Andrew C. von Eschenbach, M.D. gave a speech entitled “FDA at a Turning Point: Meeting the Challenge of a Rapidly Changing World.”

In his speech he outlined three main points.

• How the world has rapidly and radically changed
• Why these changes have brought FDA has to a turning point
• And what is being done to re-create the FDA

Gain insights into today’s and tomorrow’s FDA.
Read this speech. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1368 clients since 1996

March 19-20 Anaheim, CA
GMPs for Dietary Supplements Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
April 16-70 Anaheim, CA
Fundamentals of GMP Boot Camp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

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FDA Under Fire in Congressional Testimony - March 4, 2008

The FDA is suffering from a crisis in leadership, a lack of congressional oversight and a dangerous reliance on the pharmaceutical industry to bankroll its operations, Sidney M. Wolfe, M.D., director of the Health Research Group at Public Citizen told a House of Representatives subcommittee on February 27.

“The situation at the FDA has never been worse than now,” Wolfe said. “Congress must act quickly to restore confidence in the FDA.”

On the same day, FDA’s Commissioner, Andrew von Eschenbach, challenged Congress on Friday to quickly give his agency more teeth to regulate food safety. "This is a time to not just be critical about what is not being done, but to collaborate on what must be done," von Eschenbach said in a speech at the National Press Club. "We can't transform this agency ourselves."

GMP Tip
More evidence that will likely result in FDA taking a tougher stand with industry. Be proactive – review your systems and processes, conduct an internal audit, and schedule GMP training.

Read Dr. Wolfe’s testimony. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1364 clients since 1996

March 19-20 Anaheim, CA
GMPs for Dietary Supplements Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
April 16-70 Anaheim, CA
Fundamentals of GMP Boot Camp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.