GMP Training - FDA Perspective - Apr 29, 2008

An article in the New England Journal of Medicine entitled Trying Times at the FDA — The Challenge of Ensuring the Safety of Imported Pharmaceuticals puts some perspective into the tough times FDA has been facing recently. An accompanying article, Playing “Kick the FDA” — Risk-free to Players but Hazardous to Public Health, sheds even more light on the situation.

Read both articles. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1401 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Training - CAPA or caPA? - Apr 22, 2008

We all know that CAPA stands for Corrective and Preventive Action. Here are two questions for you.

Where do you get the greatest payback for your investment - correcting problems or preventing problems?

Where do people in your company spend their time - mostly on correcting problems or mostly on preventing problems?

By simply using caPA instead of the traditional CAPA, you can send a message to your people on what's more important and where we should be investing our resources. Hint: Share this with your management too.

An article written by David Markovitz, President of GMP Training Systems, Inc. helps reinforce this notion. Go to:
www.gmptrainingsystems.com/asp/resources.asp

Scroll down to Articles authored by David Markovitz and find Problem Solving is Not Good Enough! Problem Prevention is the Key to Success.


GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1397 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

GMP Training - FDA withdraws GMP Changes - Apr 14, 2008

The FDA withdrew a direct final rule that was published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations.

FDA is withdrawing the direct final rule because the agency received significant adverse comments. In their announcement, FDA said that it will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113).

Stay tuned.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1391 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

Use the Heparin Fiasco in Your GMP Training - Apr 10, 2008

The FDA reported on April 9 that the death toll linked to contaminated heparin now stands at 62. Read a New York Times story dated April 10 with details. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip

Use this story in your GMP training sessions to reinforce the importance of following GMP. We always ask participants in our training the following question. “What’s the worst thing that could happen if you have a product failure once your product has been shipped?” Of course the answer is somebody could die, or someone could get hurt. This is a gut check for everyone involved in the FDA regulated industries. It’s not a bad thing to remind your people of the severe consequences of not following GMP.

FDA has set up a web page dedicated to this issue.

http://www.fda.gov/cder/drug/infopage/heparin/default.htm

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1389 clients since 1996

April 16 - 17 Anaheim, CA
Fundamentals of GMP Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
June 25 - 26 Anaheim, CA
GMPs for Dietary Supplements Boot Camp

GMP Training System Now Available in Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

FDA Cites Training Failures - Apr 2, 2008

Training is an important element of GMP, and the FDA is not reluctant to cite a company for failures in this area. Here’s an actual citation from a Warning Letter issued in late February to a Medical Device manufacturer.

Failure to establish procedures for identifying training needs and for ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 C.F.R. § 820.25(b). Your firm's training of operators was inadequate in that:

• You have no document control of your operator training packet that consists of multiple, separate, non-sequentially numbered training documents.
• Your operator training protocol is not linked to your written training procedures and has no document control to include management approval prior to implementation.
• You do not have documentation of reviewing and approving an operator's training and testing records and results prior to the employee being released to receive medical alarm calls.

Read the entire Warning Letter issued to Philips Lifeline, Inc. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1384 clients since 1996

April 16 - 17 Anaheim, CA
Fundamentals of GMP Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
June 25 - 26 Anaheim, CA
GMPs for Dietary Supplements Boot Camp

GMP Training System Now Available in Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.