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Create an Inspection Readiness Gap Analysis: How to Avoid the FDA’s Top 29 483 Citations
Who's that sitting in your lobby?
Watch out … it may be your regional FDA inspector, just dropping by for an unannounced inspection of your facilities.
If this happens to you — will you be ready?
If this fictional scenario sounds like hype to you, then listen to what just happened to the folks at device and drug maker Hospira.
Late last year — with the holiday season approaching — the FDA broadsided a major pharma company with a series of warning letters at their facilities in Colorado, North Carolina, Kansas, Illinois and Costa Rica.
Why weren't the facilities better prepared? After all, many of the problems uncovered during their inspections are common within the drug and device industries.
Don't take the chance of being next in line for an unannounced inspection.
Order the webinar CD and transcript set
Create an Inspection Readiness Gap Analysis TODAY.
This set features a list of the 29 top problems that repeatedly show up in 483s and warning letters.
Dr. David Lim, an accomplished former FDA official with CDRH and a pharma executive, pulled together this 29-point hot list by combing through data from FDA inspections over the last seven years. Step-by-step, he reveals why — and how — the FDA focuses on all 29 of them
It's the best possible way to begin preparing your own inspection readiness gap analysis. In 90 minutes, you'll gain an understanding of where your facility's compliance weaknesses might be, and you'll also learn:
At a time when your compliance resources are probably scarce, Dr. Lim's FDA inspection webinar CD and transcript set is an excellent, affordable way to begin preparing your inspection readiness gap analysis.
Dr. David Lim, a former FDA employee, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia. He discovered a novel growth factor and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke University Medical Center (Duke), California Institute of Technology (Caltech), University of California at Berkeley (UC-Berkeley), US National Laboratories, Intrexon, Terumo, US FDA/CDRH, and EraGen Biosciences (Luminex Company).
In 2009, he served as a panel member during the FDA’s transparency public meeting. Prior to forming the Regulatory Doctor consultancy, Dr. Lim was the Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals.
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