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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

TOP POSTINGS FROM THE BLOG OF BARRY A. FRIEDMAN, Ph.D., LLC — 2012

January 6, 2013 By Barry Friedman Leave a Comment

Often the question is asked “what were your top postings during the previous year.  This is an intriguing question since I don’t know myself until I review the postings at the end of each year.  With an accumulation of over 70,000 views, it is of interest to determine what you, the viewers, deemed to be the most important.

I have now sorted through the various postings from this past year and find those items listed below to have warranted the most views.  Interestingly, four of the five top postings involved FDA issues and most of those involved either a Form FDA 483 or a Warning Letter.  The fifth discusses USP 61/62 and “Frequently Asked Questions”.

Rounding out the top ten views were more FDA and USP issues.  Interestingly, within this group of top views was a posting regarding upcoming webinars, seminars and conferences which was periodically updated as new events were added.  I applaud each of you for your interest in furthering your education and training.

1)  FDA Increases Vigilance on Aseptic Processing Facilities

2)  USP 61/62 Frequently Asked Questions

3)  Ben Venue Received Yet Another Form FDA 483

4)  FDA Issues — Media Growth Promotion Studies McNEIL-PPC, Deltex Pharma, Ribbon Pharma & Chemical, Columbia Presbyterian Medical Center

5)  FDA Issues Warning Letter for Clinical Supply Manufacturing Facilities

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Filed Under: 483, Consent Decree, FDA Compliance, Microbiological Issues, Regulatory Compliance, Warning Letters Tagged With: Aseptic Processing, Ben Venue, Blog, clinical supply, FDA, FDA 483, Frequently Asked Questions, Top Postings, USP 61/62, Warning Letters

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FREQUENTLY ASKED QUESTIONS:

FDA Form 483 Frequently Asked Questions

USP General Chapter

USP General Chapter 62, Part II

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FDA CDER Most Frequent Form FDA 483 Observations Fiscal Year 2012

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