An Eye-Popping Warning Letter - August 27, 2007

Sometimes you read a Warning Letter that makes your eyes pop out. Here are excerpts from one such letter recently issued to a manufacturer of contact lenses.

• The change control procedure, among others, remains unsigned and undated. Changes were observed having been made via the addition of "post-it" notes.
• No record accompanies each pair of lenses nor is a record created concurrent with each step of production.
• No audits have been performed since your firm began manufacturing in 2000.
• No acceptance procedures for finished devices have been established and device history records do not include documentation of a final review to assure lenses are manufactured in accordance with device master records.

Read the entire Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down. Look for
Crystal Reflections International Warning Letter June 14, 2007

Training Tip
Use Warning Letters in your GMP training sessions as a way to learn from other peoples’ experience (OPE).

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1243 clients since 1996

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Fourteen terrific programs currently scheduled
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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Parent's Guide to Kids' Vaccines - August 22, 2007

Many of us are preparing for Back-to-School at this time of the year. FDA just published an article entitled "A Parent's Guide to Kids' Vaccines." This is a very comprehensive guide that every parent should have. If you're a grandparent, print this and give it to your children. Planning a family? Print this and save it for future reference.

Find this article at:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1239 clients since 1996

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Thirteen terrific programs currently scheduled
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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

Schering-Plough Climbs Back - August 13, 2007

Schering-Plough announced earlier this month that a consent decree filed against the company in May 2002 had been dissolved by the US District Court. This is the court action that was issued for violations of GMP and resulted in a fine of $500 million.

What other extraordinary costs were experienced in this climb back from the abyss.

• What about the costs to peoples’ careers?
• What about the cost to peoples’ health? (Stress levels when operating under a court order are unusually high.)
• What about the cost to the company’s reputation and ability to recruit top talent?

Few companies today have the size, resources, strength, and momentum that Schering-Plough has to come back. Many companies in this situation shrink to a smaller operation, become targets for takeover, or simply go out of business.

See what Schering-Plough’s people had to do to get back into compliance. Read the 46-page Consent Decree issued to Schering-Plough in May 2002. Go to:

www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip
This entire episode could have been prevented had people in the organization been focused on GMP and making it a Lifestyle in the company. PREVENTION ALWAYS COSTS LESS THAN CORRECTION. Make sure your management team is aware of this Consent Decree and the five years it took to get back into compliance.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1235 clients since 1996

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Thirteen terrific programs currently scheduled
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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

Planning GMP Training in 2007 - August 8, 2007

Are you planning GMP training this fall?

Now is the time to start planning for programs in September – December. The logistics for training can be a challenge, especially when planning plant-wide training.

Training Tips
1. Work with your Manufacturing and Planning departments now to identify the optimum times for scheduling the training.

2. Contact GMP training suppliers now for dates in 2007. Our calendar gets quite crowded during the months of October – December.

GMP Training Systems, Inc. was founded in 1996 by David Markovitz, after gaining two decades experience in Operations Management in the industry. Learn more about our faculty at:
www.gmptrainingsystems.com/asp/about_us.asp

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1231 clients since 1996

See our entire Web Seminar schedule:
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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

Our Two-year Anniversary: THANK YOU - August 1, 2007

We started the GMP Training and Implementation Tips web portal two years ago. We express a hearty "Thank you" to our faithful readers.

This is the 102 posting - this means that there are 101 useful tips archived right here for you to use. If you are a relatively new subscriber, spend some time going through our archived postings. You'll find a treasure trove of examples to liven up your GMP training.

You can also find numerous helpful documents in our Resource section of our web site.
www.gmptrainingsystems.com/asp/resources.asp

As we start our third year, we invite you, our readers, to send in your tip. We'll publish it here and give you the credit. Send your GMP Tips to info@gmptrainingsystems.com.
Put GMP Tips in the subject line so we are sure to find it.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1225 clients since 1996

Coming soon: A comprehensive on-line GMP course consisting of twelve modules. Excellent for new employees, temporaries and contactors. We strive to make your job easier.

Our next popular GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach,CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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