Great Training Example for You

We’ve often found that reading the newspaper regularly is an excellent way to find examples to use in GMP training sessions. Here’s an article from USA Today, dated July 12, 2005, that you should find useful. It’s about a company called Able Laboratories Inc. We’re certainly going to use this as an example in our GMP training workshops.

Go to http://www.gmptrainingsystems.com/asp/articles.asp to get a copy of the article.

Learning from other's experiences is a true and tried method of learning. We have always used FDA-483s and FDA Warning Letters in our GMP workshops. Many of these can be easily found on FDA’s web site – www.FDA.gov.

On July 6, 2005, Able Laboratories received a fifteen page 483 containing twelve major observations. This follows a May 25, 2005 letter Able Labs sent to their customers launching a recall of ALL products under the Able Laboratories Inc. label.

During our GMP trainings, we’ve stressed over and over and over the importance of following the current Standard Operating Procedures. Here’s an example of what can go wrong when people don’t follow procedures.

You can get a copy of the Able Labs 483 here – http://www.gmptrainingsystems.com/asp/articles.asp

Stay tuned for further developments in this situation.

We design and conduct GMP training programs for the Pharmaceutical and Medical Device industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, GlaxoSmithkline, Merck, Baxter Healthcare, Grifols Biologicals, and several others.

Learn more about our services at www.GMPTrainingSystems.com