GMPTips - Congressional report condemns FDA - Nov 18, 2008

The U.S. Government Accountability Office (GAO), the investigative arm of Congress, recently issued a report condemning FDA’s ability to monitor foreign drug manufacturers. The GAO said the FDA has faulty records on the facilities it oversees because it doesn't require companies to update information such as corporate names and addresses annually. "FDA does not know the number of establishments subject to inspection," the report says. Currently, domestic companies are inspected about every 2.7 years, but the rate for foreign inspections is roughly once every 13 years.

The report "confirms that the system deployed by FDA to police (foreign) facilities and keep Americans safe from poorly manufactured drugs is understaffed, overwhelmed and completely inadequate," said Rep. Bart Stupak, D-Mich.

Read two news accounts and the GAO report. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1521 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Nov 25 Managing Your Staff in a Down Economy: How to Keep Your People Focused and Productive

Dec 8 Fundamentals of HPLC web course

Upcoming workshops - 2009
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

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

GMP Tips - FDA Sends in U.S. marshals to seize contaminated heparin - Nov 10, 2008

Frustrated after twice asking Cincinnati-based Celsus Laboratories, Inc. to recall contaminated heparin, the FDA sent in U.S. marshals to seize 11 lots of the blood-thinning drug.

Read two articles with details here.
www.gmptrainingsystems.com/asp/resources.asp
Select Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1519 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Nov 14 New Revisions to Drug GMP: What You Must do to Comply

Nov 25 Managing Your Staff in a Down Economy: How to Keep Your People Focused and Productive

Upcoming workshops - 2009
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

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

GMP Tips - Obama and the FDA - Nov 6, 2008

Yesterday we predicted the FDA would be strengthened under an Obama presidency. We're already seeing evidence begin to surface. Here's a headline from today, Nov 6. Obama Expected to Bolster FDA Oversight of Imports

Here's an excerpt: The FDA, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration.

With President Bush no longer a roadblock, health officials also can expect new powers to control tobacco, from cigarettes to the recently introduced smokeless products called snus.

President-elect Obama, a former smoker struggling to avoid relapse, is a sponsor of legislation giving the FDA authority to control, but not ban, tobacco and nicotine.

Read the entire article. Go to:
www.gmptrainingsystems.com/asp/resources.asp

Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1515 clients since 1996

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

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

GMP Tips - FDA in the New Administration - Nov 5, 2008

Now that the Democratic party will have control over Congress and the Presidency, can we expect a strengthened FDA?

The Democrats tend to favor more regulation. We predict that Congress will provide more funding for the FDA and that the new President will nominate a new Commissioner - one that will emphasize more frequent and stricter inspections.

Now is the time to prepare! Schedule internal audits! Schedule GMP training! Be proactive!

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1515 clients since 1996

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

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