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Barry A. Friedman, PhD LLC

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

2015 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program

June 29, 2015 By Barry Friedman Leave a Comment

7-Part Live Training Program

Starts September 30, 2015

Instructor: Barry A. Friedman Ph.D.

The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these chapters have been recently updated and all have been updated since 2009. Each of these Chapters has relevance to each other and provides a significant knowledge base of microbiological requirements. Several of these have also been harmonized and permit one to not only follow the USP, but simultaneously meet the requirements of both the European and Japanese Pharmacopeia.

This intensive annual live training program on the topic of USP Microbiological General and Information Chapters will consist of 7 live training sessions of 2 hour presentations followed by 30 minutes of live Q&A each. It will include over 17 hours of live presentation and Q&A delivered periodically over the course of 3 months. The method of delivery proves effective in providing trainees with ample time to absorb, process, and put to use the information learned, and then return to the next session with any questions, as opposed to condensing this intensive training program’s curriculum into a short seminar, and thereby saturating the audience with an overload of information.

The design and preparation of this program’s content is a result of years of practical industry experience on the part of the presenter, Dr. Friedman, ensuring that trainees will be provided with the most up to date and practical information on the topic. This multi-part live training program is instructed by Dr. Barry Friedman, who has over thirty years of experience in pharmaceuticals, biotechnology and regulatory compliance. He has worked with both large and small pharmaceutical and biotechnology companies on various aspects of non-sterile and sterile microbiology to include auditing, method validation and regulatory compliance.

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Filed Under: 483, Consent Decree, Microbiological Issues, Regulatory Compliance, Warning Letters Tagged With: Aseptic Processing, microbiological trainining, non-sterile, PharmaWebinars, sterility test USP 71, USP 61, USP microbiology

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