GMP Tips - Hurricane Advice from FDA - Aug 30, 2006
Since hurricanes are in the news again, we thought we’d point out FDA’s web resource: Hurricanes – Health and Safety Before and After a Storm.
Find this valuable resource at:
www.fda.gov/oc/opacom/hottopics/hurricane.html
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GMP Tips - Validation Week - Save $$$ - Aug 24, 2006
David Markovitz, Founder and President of GMP Training Systems, Inc., will be speaking at the Institute of Validation Technology (IVT) Validation Week conference in Philadelphia on October 25. In partnership with IVT, we are pleased to offer you $200 off the conference tuition. Go to www.gmptrainingsystems.com/asp/ivt_Valweek2006.asp where you can download a conference brochure and the $200 off coupon. See you in Philadelphia!GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 874 clients since 1996Our next GMP Boot Camp is scheduled for November 15 - 16 in Anaheim, CA. These fill up fast. For registration information, go to:www.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
GMP Tips - Are We Getting Closer to an FDA Commissioner? - August 21, 2006
President George W. Bush has come under increasing pressure from anti-abortion groups to withdraw his nomination of Andrew von Eschenbach to the post of FDA Commissioner.
At his Press Conference on Monday, Aug 21, President Bush was asked about his support for von Eschenbach and his recent decision to seek over-the-counter (OTC) status for the emergency contraception drug Plan B, more commonly referred to as the “morning after” pill. When asked by reporter Bill Sammon about the situation, Bush stated: “I believe that Plan B ought to be -- ought to require a prescription for minors, is what I believe. And I support Andy's decision.”Von Eschenbach's nomination to the permanent job of commissioner has been held up for months by Democrats who assert that the decision on Plan B has been delayed for political reasons.In July, Von Eschenbach said Plan B could be used safely and effectively for women 18 and older as long as younger people could not buy it without a doctor's note.Plan B, approved as a prescription in 1999, is a set of two high-dose hormone pills that can prevent pregnancy if taken within 72 hours of sexual intercourse.Test your political instincts. Do you think the Senate will confirm von Eschenbach, or will his confirmation continue to be blocked until after the election, when Democrats hope to have a majority in the Senate? Send us an e-mail at info@GMPTrainingSystems.com with your prediction.GMP Training Systems, Inc.
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GMP Tips - FDA Enforcement Report - August 16, 2006
Some interesting observations were contained in FDA's Enforcement Report last week.Recent recalls cited the following reasons: 1. Packaging mix-up: The outer packaging is labeled as Hydralazine Hydrochloride, 100 mg tablets, but the unit dose blister strips inside the outer packaging may contain and be labeled as Benztropine Mesylate, 0.5 mg tablets.2. Lorazepam 1 mg tablets packaged and distributed as Lorazepam 2 mg tablets.3. Labeling: Incorrect package insert (older version) was sent instead of revised current version.Read these GMP violations and others at:http://www.gmptrainingsystems.com/asp/resources.aspClick on FDA Resources and scroll down to FDA Enforcement Report Aug 9, 2006Training TipUse examples like these in your GMP Training sessions to reinforce the need to follow procedures.GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 854 clients since 1996Coming soon! Our Interactive Computer-based GMP Training System. Order before August 31 and save 50%.Find out how at http://snipurl.com/GMPCBTPlease forward this post to others in your organization who might benefit.
GMP Tips - Being Prepared for FDA Inspections: More Important then Ever – August 8, 2006
What effect will the politics looming over the confirmation of the next FDA Commissioner have on the rank and file FDA employees? Think about it. Since January of 2001, a period of 67 months, FDA has been led by two Commissioners for a total of 18 months (Mark McClellan for 16 months and Lester Crawford for 2 months and two weeks). The remaining 51 months FDA has been led by Acting Commissioners (Lester Crawford and now Andrew von Eschenbach).
With the controversies FDA has found itself in with Vioxx and other drug withdrawals and black box warning approvals, the contaminated flu vaccine from 2004, and now the politics raging around the Plan B contraceptive, FDA’s leadership has come under a lot of fire. The heat is turned way up!
Might we expect those folks working for FDA that conduct plant inspections to be a little more thorough in their inspections? Not be willing to grant the benefit of the doubt to those undergoing scrutiny?
Any organization undergoing stress at the top is bound to have trickle down effects. There can be no clear direction or mandates from above when top management is under fire themselves. And even if new mandates are given, who’s to say when a new Commissioner may appear on the scene and change things.
There’s no doubt that the troubles FDA finds itself in will affect different employees differently, but one thing is certain, they will all be affected.
Training Tip
Be prepared. Make sure your GMP training is up to date. Make sure the review of your SOPs is current. This is a good time to schedule an internal audit. Find out if there are gaps in any of your systems, then put a program in place to address those gaps. Don’t let the FDA inspection team be your auditors. Stay ahead of the curve. This is the time to be proactive.
GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 839 clients since 1996Coming soon! Our Interactive Computer-based GMP Training System. Order before August 31 and save 50%.Find out how at http://snipurl.com/GMPCBTPlease forward this post to others in your organization who might benefit.
GMP Tips - FDA Commissioner Confirmation Embroiled in Politics - August 3, 2006
President Bush's nominee to head the Food and Drug Administration, Andrew von Eschenbach, currently FDA Acting Commissioner, doesn't look much closer to confirmation following a Senate hearing held this week.
No senator questioned Andrew von Eschenbach's qualifications to lead the FDA. But several say they won't allow a vote on his nomination until the FDA rules one way or the other on a three-year-old request to sell the morning-after birth control pill without a doctor's prescription.
Von Eschenbach told the drug's manufacturer Monday he's willing to discuss the matter further, but he declined to give the senators a specific timetable for a decision.
That leaves the most likely scenario a recess appointment by President Bush. Senators warned such an act would be considered highly provocative, but they would have little recourse.
Read more in an article published in the Philadelphia Daily News on August 3, 2006.
Go to www.gmptrainingsystems.com/asp/resources.aspClick on Timely Resource Articles.
GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 829 clients since 1996Coming soon! Our Interactive Computer-based GMP Training System. Order before August 31 and save 50%.Find out how at http://snipurl.com/GMPCBTPlease forward this post to others in your organization who might benefit.
