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

MOST FREQUENTLY VIEWED POSTINGS — YEAR TO DATE FROM THE BLOG OF BARRY A FRIEDMAN, PhD

September 5, 2012 By Barry Friedman Leave a Comment

Periodically individuals have contacted me to learn of the “most frequently viewed postings” on my Blog.  On occasion, I ask myself the same question.  As a result I am posting the “top six” requested sites for your review.  You may find one or more of these postings of interest to you.  Each of these remains available and is easy to locate through the “Search” function and using one or more key words in the title or by reviewing the headers on the title page, e.g., “2012 Upcoming Webinars…”.

I would also personally like to thank each of you for visiting this site and contributing by offering comments.  Should you be attending the PDA/FDA meetings next week in Baltimore (September 10/12), the PDA Micro meetings in Bethesda (October 22-24 and 26) or the Pharmig meetings in Chipping Norton, England (November 5 -7), please stop by and introduce yourself.  It’s always great to have a one-on-one conversation with new friends as well as renew old friendships.

MOST FREQUENTLY VIEWED POSTINGS — YEAR TO DATE

1)  FDA Increases Vigilance on Aseptic Processing Facilities

2)  Ben Venue Receives Yet Another Form FDA 483 (12/2/11)

3)  USP 61/62 Frequently Asked Questions

4)  Ben Venue Laboratories Receives Form FDA 483 for Aseptic Processing Issues (5/25/11)

5)  FDA Issues Warning Letter for Clinical Supply Manufacturing Facilities — February 10, 2011

6)  2012 Upcoming Webinar/Conferences/Seminars (Updated 8/24/12)

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Filed Under: 483, Consent Decree, FDA Compliance, Microbiological Issues, Warning Letters Tagged With: Aseptic Processing, Ben Venue, clinical supply manufacturing, conferences, FDA, PDA, seminars, USP 61/62, webinars

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Webinar Registration & Information

FREQUENTLY ASKED QUESTIONS:

FDA Form 483 Frequently Asked Questions

USP General Chapter

USP General Chapter 62, Part II

TOP OBSERVATIONS:

FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014

FDA CDER Most Frequent Form FDA 483 Observations Fiscal Year 2012

CDER MOST FREQUENTLY CITED DRUG OBSERVATIONS – FISCAL YEAR 2010

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