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Barry A. Friedman, PhD LLC

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

Upcoming Microbiological Webinars

July 31, 2020 By Barry Friedman Leave a Comment

Enclosed are a series of upcoming microbiological webinars which are being offered between now and the end of September.  While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing.  Just click on the title of each webinar to gain additional information or … [Read more...]

Microbiological Webinars

May 11, 2020 By Barry Friedman Leave a Comment

Enclosed are a series of upcoming microbiological related webinars which are being offered between now and the middle of June.  While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing.  Just click on the title of each webinar to gain … [Read more...]

Microbiological Webinars 2020 (Upcoming)

April 26, 2020 By Barry Friedman Leave a Comment

Enclosed are a series of upcoming microbiological related webinars which are being offered between now and the middle of June.  While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing.  Just click on the title of each webinar to gain … [Read more...]

General Chapter (USP<60>) on B. cepacia Complex to Issue December 1, 2019

February 19, 2019 By Barry Friedman Leave a Comment

Pharmacopeial Forum (PF, September/October 2018, 44(5)) published a new, proposed General Chapter (USP<60>) on B. cepacia Complex entitled “USP<60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex”.  The proposed PF chapter represents an expansion of USP<62> Microbiological Examination of Nonsterile Products: Tests for … [Read more...]

Milbar Laboratories Receives Warning Letter (July 23, 2018) for Failure to Meet Purified Water Specifications

August 5, 2018 By Barry Friedman 1 Comment

Milbar Laboratories Receives Warning Letter (July 23, 2018) for Failure to Meet Purified Water Specifications.  The U.S. Food and Drug Administration (FDA) inspected Milbar Laboratories located at 20 Commerce Street, East Haven, CT from December 7–27, 2017.  On July 23, 2018 they received a Warning Letter based on their audit. Several notable Observations included those … [Read more...]

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  • Upcoming Microbiological Webinars
  • Microbiological Webinars
  • Microbiological Webinars 2020 (Upcoming)
  • General Chapter (USP<60>) on B. cepacia Complex to Issue December 1, 2019
  • Les Produits Chimiques B.G.R., Inc. Receives FDA Warning Letter (07/24/2018) for Failure to Perform Laboratory Testing

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