Centennial of 1906 Pure Food and Drugs Act

Our research during our thirty years in the FDA regulated industry has shown that when people in an organization commit to abide by GMP and other regulatory laws and guidelines, there are fewer problems in that organization. We have found that there is a BIG difference between commitment and compliance.

People will comply because they HAVE to.

People will commit because they WANT to.

We have used the history of the FDA and the evolution of regulations as an effective method in helping people understand the conditions that led to the regulations in the first place. This year marks the centennial of the 1906 Pure Food and Drugs Act. FDA is planning a series of articles to commemorate this centennial year.

Read the first article in this series here - http://www.gmptrainingsystems.com/asp/resources.asp
Scroll down to FDA Resources and click on Upcoming Centennial of the 1906 Pure Food and Drugs Act

Use the information from this article to enhance your GMP training and move your people from compliance to commitment.

GMP Training Systems, Inc.
Experience You Can Trust!
www.GMPTrainingSystems.com

David Markovitz, Founder and President of GMP Training Systems, Inc., has developed a unique method of teaching the history of GMP.

Click here to learn how he does it.
http://www.gmptrainingsystems.com/asp/evolution.asp

FDA Issues New Guidance Document

FDA issued a new Guidance for Industry on January 11, 2006. It is titled Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP.

This guideline was prepared by FDA’s Dispute Resolution Working Group formed as part of the August 2002 FDA Initiative - Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach.

Download a copy of this new guidance document here. http://www.gmptrainingsystems.com/asp/resources.asp
Scroll down to FDA Resources

GMP Training Systems, Inc.
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www.GMPTrainingSystems.com

Our GMP Boot Camp covers the Fundamentals of GMP
February 7-8 in Virginia and April 5-6 in California

The Slow Road Back

Schering-Plough Corporation met a Dec. 31, 2005 deadline to revamp its current good manufacturing practices, as mandated by the US Food and Drug Administration in a 2002 consent degree.

According to the company, Schering-Plough completed all of the 212 significant steps and 30 validation actions required by the FDA, and is awaiting approval by the agency and third-party certification after an upcoming review process.
It has taken nearly three-and-a-half years for Schering-Plough to revalidate and work out deficiencies in their manufacturing plants that led to $500 million in fines and the suspension of approximately 70 products.

Training Tip

Download a copy of the Consent Decree issued to Schering-Plough. Read through it and create a summary of what they were required to do. Use the summary in GMP training sessions to give people a sense of the breadth of observations and the power FDA wields in our industry.

The fundamental question to have training participants ponder is which is costlier – complying with GMP in the first place, or paying the $500 million in fines and paying for the three and one-half years of compliance actions.

Another question to ponder is whether Schering-Plough has been a fun place to work these last few years. Generally working under a Consent Decree is oppressive, and certainly not fun.

Stay Tuned

Schering-Plough still has to pass muster with FDA before the Consent Decree can be lifted.

Download the Consent Decree here - www.gmptrainingsystems.com/asp/resources.asp
Scroll down to Timely Resource Articles.

GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com

Our GMP Training System is now available in Spanish!

Guidant Gets Lump of Coal in Christmas Stocking

On December 22, 2005, just three days before Christmas, Guidant Corporation received a Warning Letter from FDA detailing 8 significant deviations. This follows an FDA-483 issued in September 2005 listing 15 major observations.

The last paragraph of the Warning Letter says, "Please notify this office within 15 working days of receipt of this letter and provide an update on the status of your corrective actions."

The letter was sent Certified Mail – Return Receipt Requested.

Training Tip:

Print copies of both the FDA-483 and Warning Letter to use during a GMP training session. Discuss the impact of these FDA actions on the company.

Here are some tips on starting the discussion:

• When many people are taking time off to enjoy the holidays, Guidant’s employees are gathering to prepare their response to FDA. Imagine the impact on morale within that company.
• The cost associated with compliance activities is likely to take a big chunk of the 2006 budget, potentially leaving less for salary increases, bonuses, and profit sharing.
• Have your people come up with other potential consequences.
  

Download the FDA-483 and the Warning Letter at

www.GMPTrainingSystems.com/asp/resources.asp

Scroll down to Timely Resource Articles.

GMP Training Systems, Inc.
Experience You Can Trust!
www.GMPTrainingSystems.com