Wednesday, September 27, 2006

GMP Tips - Safe Medical Devices for Children - Sept 27, 2006

Requested by Congress, Safe Medical Devices for Children, a report generated by the Institute of Medicine of the National Academies, evaluates the FDA's postmarket surveillance of medical devices used with children specifically. (This report is a 480 page book.)

Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart.

Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines:

  • The Food and Drug Administration's monitoring and use of adverse event reports.
  • The agency's monitoring of manufacturers fulfillment of commitments for postmarket studies ordered at the time of a device s approval for marketing .
  • The adequacy of postmarket studies of implanted devices to evaluate the effects of children s active lifestyles and their growth and development on device performance.

Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.

The National Academies perform an unparalleled public service by bringing together committees of experts in all areas of scientific and technological endeavor. These experts serve pro bono to address critical national issues and give advice to the federal government and the public.

Find the book here:
http://newton.nap.edu/catalog/11313.html

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Wednesday, September 20, 2006

GMP Tips - FDA Issues New Guidance on CGTP - Sept 20, 2006

The Food and Drug Administration (FDA) is reminding companies that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) that they must comply with FDA regulations. A new Guidance for Industry: Compliance with 21CFR Part 1271.150(c)(1) – Manufacturing Arrangements was issued on September 8, 2006. (Don’t you just love the memorable titles FDA gives to these documents?)

The issuance of the guidance to industry follows two recently identified cases of serious violations of safety requirements pertaining to the recovery of tissues, and subsequent FDA actions to stop the operations.

"Patient safety is our primary concern," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research (CBER). "This guidance serves to emphasize the important role that manufacturers play in enhancing tissue safety by helping to ensure that those that perform work for them also comply with the regulations.

CGTP is Current Good Tissue Practices introduced in 2005.

Read this new guidance document. Go to:
http://www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

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Wednesday, September 13, 2006

GMP Tips - FDA Whistle Blower Speaks Out Again - Sept 13, 2006

In an editorial published Sept 12, 2006 on the Journal of the American Medical Association's (JAMA) website, Dr. David J. Graham is once again is speaking out about new arthritis drugs. He says, "The FDA, academia, and the medical research enterprise are once again faced with the opportunity to forsake common sense by willfully accepting misdirection and disinformation presented in the guise of science.”

Graham, a physician in the FDA's Office of Drug Safety, made news nearly two years ago when he told a Senate panel that the agency was "virtually defenseless" in preventing a "tragedy and profound regulatory failure" such as Vioxx. Vioxx was withdrawn by manufacturer Merck in 2004.

Graham is a high ranking employee of the FDA, and the FDA allowed Graham to write the editorial as a private citizen, not as an agency employee. (Interesting.) The editorial and the two studies it accompanies will run in the Oct. 4 JAMA, but they were posted online early "because of the public health implications," a JAMA press release says.

Read more about this development in an article appearing in USA Today, Sept 12. You can also find Dr. Graham’s editorial listed. Go to:
http://gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down to find these two documents.

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Sunday, September 10, 2006

GMP Tips - American Red Cross Fined $4.2 Million - Sept 10, 2006

FDA announced on Sept 8 that the American Red Cross is being fined $4.2 million for failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products. The violations include breaches of Good Manufacturing Practice (GMP) such as a failure to ask appropriate donor screening questions and failure to follow manufacturer test protocols.

Since entry of the 2003 Consent Decree and prior to this action, FDA has issued the American Red Cross seven similar letters and assessed a total of $5.7 million in penalties.

Some organizations get it, and some don't.
Don't you think investing in effective GMP training could have prevented this?

GMP Training Systems, Inc. could have conducted the training for American Red Cross for less than $4.2 million. We could have charged them $3 million, and saved them $1.2 million. What a deal! Just kidding - we have reasonable rates - just call us to find out how we can help you prevent situations like this one.

Read FDA's Press Release explaining the reasons for this action. Go to:
http://gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down to the entry labeled American Red Cross fined by FDA.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
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Thursday, September 07, 2006

GMP Tips - Use Warning Letters to Gain Insights - Sept 7, 2006

Using FDA Warning Letters in your GMP training is an effective way to reinforce specific aspects of Good Manufacturing Practice. Recently, a Warning Letter was issued to a manufacturer of medical devices. This short (three-page) Warning Letter identifies three specific areas of concern:

  1. Failure to establish and maintain quality requirements for suppliers and contractors.
  2. Documentation of the monitoring and control methods during validation of processes.
  3. Failure to analyze complaints.
Read the details of what FDA addressed and you will gain insights into what FDA looks for when conducting an inspection. Go to:
http://gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down to the entry labeled Command Medical Products Warning Letter.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 912 clients since 1996

Our next GMP Boot Camp is scheduled for
November 15 - 16 in Anaheim, CA. These fill up fast.
For registration information, go to
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