Tuesday, October 30, 2007

Keeping Current with GMPs - Oct 30, 2007

We all know that the "c" in cGMP stands for current. A recent Warning Letter has proven helpful in better understanding the importance of keeping current. This Warning Letter was issued to a compounding pharmacy - which often manufactures drug products in an environment that is not cGMP compliant.

Reading FDA's commentary in this Warning Letter and the associated observations (24 majors) makes for an an interesting case study in why it's critical to stay current.

To read the letter, go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1278 clients since 1996

GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

JUST RELEASED! NEW!
Our on-line GMP Training System, twelve modules, is up and ready to go. Perfect for new and temporary employees.

www.gmptrainingsystems.com/asp/Web_based_training.asp

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

Monday, October 22, 2007

Law and Order Takes on the FDA - Oct 22, 2007

David Markovitz here with another personal story.

Last week I was watching my favorite TV show, Law and Order: Criminal Intent. It’s the one with quirky Detective Goren, a modern day Columbo. The plot revolved around a counterfeit mouthwash contaminated with DEG (diethylene glycol). An FDA Field Investigator discovers the contaminated mouthwash after children die and writes a memo to his superiors recommending an immediate recall. The FDA Regional Director shreds his copy to protect his college buddy, now the head of the pharmaceutical company targeted by the counterfeiters. The Deputy Director has her eye on the Director’s job, murders the Field Investigator using a counterfeit asthma inhaler (with no active ingredient) and tries to frame her boss in order to get his job. Of course, the detectives figure it out and arrest the Deputy Director of the FDA.

Now the Real World FDA
The FDA has been pummeled by the media and members of Congress in the past three years for a series of contaminated products, product withdrawals, recalls, a convicted Commissioner, the plan to close and consolidate labs, and other issues. Now a popular television show portrays the FDA in the worst possible light.

What Can We Expect from the FDA?
Expect FDA inspections to continue to be tough and get even tougher as they fight this image of incompetence, ineptness, and not caring for the consumer. In the TV show, the only FDA rep who cared for the consumer ended up dead.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1273 clients since 1996

Next GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

JUST RELEASED!
Our on-line GMP Training System, twelve modules, is up and ready to go. Perfect for new and temporary employees.

www.gmptrainingsystems.com/asp/Web_based_training.asp

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

Tuesday, October 16, 2007

Tylenol's "I Promise" campaign wins our praise - Oct 16, 2007

David Markovitz, President of GMP Training Systems, Inc. here to tell you a personal story.

"Last week while watching television I saw a remarkable ad for a drug product we're all familiar with - Tylenol. What was remarkable was that it featured employees who make Tylenol telling us about the care that they personally put into their jobs and their promise to do everything not to betray our trust. WOW! Quite different from the "Go tell your doctor you need ....." advertising that has become so prolific on our TV screens lately."

See for yourself - go to:
http://www.tylenol.com/promise

Training Tip
Maybe you can't launch a national advertising campaign from your office, but surely there's some element of this approach you can emulate in your company. How about an ad campaign within your company reminding people how important each job is, how each person in their own way contributes to a product that customers trust in?

Congratulations to McNeil Consumer Healthcare for this refreshing approach to marketing their product - touting their GMP compliance in terms their customers can understand and embrace.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1270 clients since 1996

Next GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Timely programs currently scheduled plus archived programs available on CD.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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

Sunday, October 07, 2007

Contamination Leads to Company Demise - Oct 7, 2007

A 67 year-old company that manufactured hamburgers for its own brand and some of the largest private label brands on the market has been forced to recall so much meat that it is going out of business.

Topps Meat Company LLC announced that because of the economic impact of the second-largest beef recall in U.S. history involving more than 21.7 million pounds of ground beef products, it is forced to close its Elizabeth plant and go out of business immediately. The company has been in business since 1940.

The tons of frozen ground beef products were recalled because they may be contaminated with E. coli.

"This is tragic for all concerned," said Anthony D’Urso, Topps chief operating officer. "In one week we have gone from the largest U.S. manufacturer of frozen hamburgers to a company that cannot overcome the economic reality of a recall this large. We sincerely regret the impact this will have on our employees, our customers and suppliers, and the community.”

Read the entire news report. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip

A sad example of how contamination can harm customers, destroy a company, throw people out of work, and impact a community. Use this example in your GMP training to emphasize the need to keep things clean.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1267 clients since 1996

Next GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Timely programs currently scheduled plus archived programs available on CD.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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

Monday, October 01, 2007

Personal Productivity - Oct 1, 2007

Have you ever been frustrated in getting your ideas for improvement accepted?

Learning how to "sell" your ideas effectively can help you propel your career forward.

We've recently found a terrific short e-book which offers great tips on how to do this well. Find it in our new section on Personal Productivity on our Resource page. It's free!
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1264 clients since 1996


Next GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Twelve terrific programs currently scheduled plus archived programs available on CD.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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