FDA Under Fire - AGAIN! Apr 24, 2007

FDA is once again being criticized for its actions (or shall we say inactions) with the recent spate of recalls. The Washington Post reported that FDA was aware of contamination problems at a Georgia peanut butter plant years before a salmonella outbreak. An FDA report shows that FDA inspectors checked into complaints about contamination in a ConAgra Foods plant in Georgia in 2005. This plant has now been closed.

Congress has scheduled hearings this week on the issue of contamination in our food supply. Stay tuned.

PREDICTION
Expect the FDA to adopt a Get Tough policy in their inspections.

Read the Washington Post story. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1117 clients since 1996

Upcoming programs:
Troubleshooting HPLC Pumps and Autosamplers
Audio seminar Apr 27
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp Jun 6 – 7 Anaheim, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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Another recall - CONTAMINATION AGAIN! - April 16, 2007

Last week FDA announced a voluntary nationwide recall of all lots of Listerine Agent Cool Blue Plaque-Detecting Rinse.

The FDA said the manufacturer of the rinse, McNeil-PPC Inc., a Johnson & Johnson subsidiary, decided to recall approximately 4 million bottles after finding the rinse had been contaminated with microorganisms.

Training Tip
In your GMP training session, have small groups discuss ways in how this contamination may have occurred. Then ask them to provide measures which could be implemented to prevent such contamination. You can also ask them to discuss all the costs associated with this recall and its impact on the company.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1103 clients since 1996

Upcoming audio seminars:
Principles of HPLC Troubleshooting April 20
A Case Study in Commissioning and Validation Apr 25
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp Jun 6 – 7 Anaheim, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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When Will They Ever Learn? - Apr 10, 2007

On March 13, Abbott Laboratories, Inc. received another Warning Letter from FDA, this time for their Diagnostics Division operation in Dallas. This follows a Consent Decree that the Abbott Diagnostics Division received from FDA in 1999 for the Abbott Park operation in Illinois.

Some of you may remember the 1960’s folk song, Where Have All the Flowers Gone?, and the chorus from that song, that goes “When Will They Ever Learn?”

Dealing with Warning Letters and Consent Decrees adds a tremendous cost burden on any company. It also adds a tremendous stress burden on the employees.

These FDA actions are best avoided simply by:

1. Keeping current on cGMP regulations.
2. Following cGMP regulations.

Training Tip
Use these two documents in your GMP training to emphasize the benefit of compliance and the perils of non-compliance. Lead a discussion on all the consequences and ramifications companies face when issued documents like these from FDA.

Read Abbott’s latest Warning Letter and the 1999 Consent Decree. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

See Mary Travers and the Kingston Trio perform Where Have All the Flowers Gone?
http://www.youtube.com/watch?v=vg8Db7VNgL0

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1097 clients since 1996

Upcoming programs:
A Case Study in Commissioning and Validation
Audio seminar Apr 25
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp Jun 6 – 7 Anaheim, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

Please forward this post to others in your organization who might benefit.

Quality Systems - Are you making progress? - Apr 2, 2007

Last week, David Markovitz, President of GMP Training Systems, Inc. lectured on Implementing FDA’s Quality System Guidance at a conference on Quality Systems sponsored by Advanstar Communications and the Institute of Validation Technology.

Last October David conducted this same program as an audio seminar. The audio recording of this seminar as well as the handout is available for purchase. Go to:
www.gmptrainingsystems.com/asp/lcgc_archives.asp
Click on Archived audio seminars.

We have also posted an FDA presentation on Implementing Quality Systems on our Resource section. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down to find this presentation by Chris Joneckis, PhD FDA CBER from August 2006.

Announcing a NEW workshop on Implementing FDA’s Quality Systems Approach to Pharmaceutical cGMP Regulations - June 6 – 7 in Anaheim, California.
To register, go to:
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1084 clients since 1996

Last call for our GMP Boot Camp on April 18 - 19
in Anaheim, CA. Learn more at:
www.gmptrainingsystems.com/asp/public_workshops.asp

Our next Statistics Boot Camp is May 23 - 24
in Washington, DC.Introduction to Statistical Methods for FDA Regulated Industries. Learn more at:
www.gmptrainingsystems.com/asp/public_workshops.asp

Please forward this post to others in your organization who might benefit.