New FDA Guideline for Medical Devices
On May 22, FDA announced their new Medical Device Innovation Initiative, which includes a new guidance document. This guidance is aimed at developing shorter and less expensive clinical trials through the use of Bayesian statistics.Read FDA's Press Release, the Guidance Document, and the description of the Medical Device Innovation Initiative. Go to http://www.gmptrainingsystems.com/asp/resources.asp Scroll down or click on Medical Devices to find these three important documents.GMP Training Systems, Inc.Experience You Can Trustwww.GMPTrainingSystems.comOur next GMP Boot Camp is scheduled for July 19 - 20 in Orlando. This workshop covers the Fundamentals of GMP and QSR. Call 714-289-1233 to reserve your space.
Bausch and Lomb issues recall - FINALLY!
On May 16, four weeks after declaring that ReNu with MoistureLoc is "as safe and effective as anything on the market," Bausch and Lomb decided to recall this product throughout the world. We first found out when we saw a full page ad in USA Today and the Wall Street Journal. (Wonder that those ads cost? Think more than the cost of providing some quality GMP training? We also saw a television ad featuring Bausch and Lomb's CEO explaining the recall on May 21 during evening prime time hours on a major network - $$$$$)
Do you suppose their decision to issue a recall had anything to do with the eleven-page FDA 483 they received from FDA on May 15?
Read the FDA 483 Bausch and Lomb received from FDA at http://www.gmptrainingsystems.com/asp/resources.asp Click on Timely Resource Articles.
Training Tip
Use this example in your GMP training sessions to demonstrate what could happen when not following GMP. Send this FDA 483 to your senior management with a note posing the following question. "Which is more expensive - Conducting effective GMP and job skills training or managing a recall?
FDA’s inspection was from March 22 to May 15. Think the stress level was up at Bausch and Lomb during that time?
Do you think this will impact consumers' confidence in Bausch and Lomb? Stay tuned.
GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com
Our GMP Roundtable starts on May 25. Join industry professionals from around the world in this innovative teleconference session. Call us at 714-289-1233 to learn how you can benefit from participating.
Executives convicted
During the course of conducting GMP training, one question that always arises is "Do people go to jail for violations of Food and Drug laws and regulations?" The answer is Yes. It's not an everyday occurrence and those convicted usually don't have job titles like Production Technician II or Forklift Driver.Read an FDA Press Release about recent convictions of two executives of a medical device manufacturer. Two other executives pled guilty. Go to www.GMPTrainingSystems.com/asp/resources.asp to see the Press Release. Click on Timely Resource Articles.
Training TipUse documents like this Press Release in your GMP training to reinforce the need to follow GMP and the seriousness of the business of manufacturing pharmaceuticals, medical devices, and other products regulated by FDA.GMP Training Systems, Inc.Experience You Can Trustwww.GMPTrainingSystems.comOur next GMP Boot Camp is scheduled for July 19 - 20 in Orlando. These fill up fast. Call 714-289-1233 to reserve your space.
FDA Withdraws Controversial Rule
In January 2006, FDA issued a proposed rule exempting phase I investigational drugs and biologics for human clinical trials from the requirement to follow CGMP regulations. FDA announced today (May 1) that this proposed rule is being withdrawn because significant adverse comments were received.We conducted an audio seminar on this controversial change on March 9, approximately three weeks before the deadline for comments. We had an impact! Our session was called Chipping Away at the GMPs: Understanding FDA's Proposal to Exempt Material for Phase I Clinical Trials from CGMP Regulations. Our guest presenter, Barbara Immel, presented an impressive argument that this move to exempt phase I investigational drugs and biologics was not a good idea. Apparently, enough of you agreed and let the FDA know your thinking.Read FDA's announcement withdrawing the rule at www.gmptrainingsystems.com/asp/resources.aspGMP Training Systems
Experience You Can Trust
www.GMPTrainingSystems.comIf you missed last week's audio seminar - Effectively Implementing Process Analytical Technology (PAT), you can purchase the CD, handouts, and written transcript of this popular program. Go to www.gmptrainingsystems.com/asp/lcgc_archives.asp to find it as well as our other archived audio seminars.
