2007 or 1907? - March 20, 2007
Last fall it was contaminated spinach.Last month it was contaminated peanut butter.This week it's contaminated pet food.Sounds more like 1907, not 2007.Actually it was 1906 when the Pure Food and Drugs Act was enacted. This followed an outcry of contaminated foods and drug products.We have three interesting articles about this era available.
Go to:www.gmptrainingsytstems.com/asp/resources.aspClick on FDA Resources. Scroll down to:Centennial of the 1906 Pure Food and Drugs ActThen scroll down to Timely Resources Articles and find:Centennial of The JungleHow Theodore Roosevelt Made Your Dinner Safe to EatWith all this attention on contamination, look for Congress to put pressure on FDA to ENFORCE, ENFORCE, ENFORCE. Be prepared. This is the time to conduct internal audits and take action to make any corrections.GMP Training Systems, Inc.
www.GMPTrainingSystems.comServing 1077 clients since 1996Our GMP Boot Camp on April 18 - 19
in Anaheim, CA is filling up fast. Learn more at:www.gmptrainingsystems.com/asp/public_workshops.aspOur 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.aspPlease forward this post to others in your organization who might benefit.
Big Batch of Warning Letters - March 13, 2007
The FDA issued thirty eight Warning Letters in February 2007. Eight of these were to pharmaceutical or medical device manufacturers for cGMP violations.
Find those eight Warning Letters at
http://www.gmptrainingsystems.com/asp/resources.aspClick on Timely Resource Articles and scroll down.
Training Tip
Use information from these Warning Letters to reinforce your GMP training efforts. Warning Letters can make for good case studies and can trigger meaningful discussion during training sessions.
GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1069 clients since 1996Our next GMP Boot Camp is April 18 - 19in Anaheim California. Learn more atwww.gmptrainingsystems.com/asp/public_workshops.aspOur next Statistics Boot Camp is May 23 - 24 in Washington DC.Introduction to Statistical Methods for FDA Regulated IndustriesPlease forward this post to others in your organization who might benefit.
Analyzing Customer Complaints - March 5, 2007
In our workshops, we often challenge the participants with the following question – “Are customer complaints good news or bad news?”
The answer is “Yes.”
The bad news part is something’s amiss. The good news part is that the customers who take the time to complain are giving us two things. 1) They’re giving us a second chance to keep them as customers. 2) They’re giving us valuable data on what needs to be improved.
Note: The vast majority of unhappy customers don’t even complain - they just go somewhere else. We’ve lost them as customers.
When we do get feedback in the form of complaints, the big question is “What do we do with it? Do we analyze it for trends or patterns? Do we make appropriate changes to our systems and processes to prevent those problems from occurring in the future?”
This is exactly what FDA expects us to do with complaint data. Here’s an excerpt from a Warning Letter recently issued to Edwards Life Sciences LLC.
“There is no documentation that the numerous open complaints from 2000 to the present were analyzed to identify existing and potential nonconforming product, or to determine whether corrective and preventive actions were necessary.”
Read the entire 8 page Warning Letter. Go to:
http://www.gmptrainingsystems.com/asp/resources.aspScroll down to Timely Resource Articles
GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1063 clients since 1996Our next GMP Boot Camp is April 18 - 19in Anaheim California. Learn more atwww.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
