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USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments and Its Comparison & Contrast to FDA’s Guidance; Aseptic Processing (2004) and Annex 1 (2009)

Live, Interactive Training Webinar

Date: Tuesday May 28, 2019 - Time: 9:30 AM - 11:30 AM (Eastern New York Time)
Instructor: Barry Friedman Biography>>>

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In May 2012 the United States Pharmacopeia (USP), Rev. 35, implemented the long awaited revision of USP General Information Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments.

This Chapter provides information and recommendations for environments where the risk of microbial contamination is controlled by aseptic processing. It further discusses the importance of a microbiological evaluation program for controlled environments. These areas will be compared and contrasted to FDA's Guidance for Industry re: Sterile Drug Products Produced by Aseptic Processing (2004) and EMA's Annex 1 (2009).

Various changes will also be discussed. Within the revised USP<1116>, microorganisms within the ISO CLASS 5, 6, 7 and 8 areas lose some of their historic emphasis on Alert and Action Levels and reflect trending -- especially in the ISO CLASS 5 and 6 areas. People recognize that it is not possible to maintain a "sterile" Aseptic Processing Area (APA) and wherever people are present, microbial contamination will also be there. Because the current thinking emphasizes trends, USP<1116> allows for the possibility of single plate contamination levels as high as 15 CFU (Out of Trend) , but quickly states should this occur, an investigation will be required. This leads to a Table that discusses frequencies which "back into" the other two accepted methodologies (FDA and EMA, see above).

The objective of this live training webinar is to review this revised document and explore changes to this revised USP Information Chapter, compare and contrast it to FDA's Guidance for Industry, Aseptic Processing (2004) and Annex 1 (2009) and how it impacts the typical Aseptic Processing Area.

Learning Benefits:
-Understanding the regulatory expectations for the revised USP <1116> .
-Integrating USP<1116> with FDA's Aseptic Processing Guidance and Annex 1.
-What the new "Suggested Initial Contamination Recovery Rates" mean to you.
-What happens when one has significant excursions .
-Acceptance criteria required to meet microbiological Clean Room specifications.
-The impact on the identification of microbial isolates .

Webinar outline and time breakdown:

Date: Tuesday December 5, 2017

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Definitions,
Reviewing the background of revised USP <1116>,
Understanding the regulatory expectations for the revised USP<1116>,
Integrating USP <1116> with FDA's Aseptic Processing Guidance & Annex 1,
How to manage "significant" excursions,
10:30 AM Break
10:40 AM Trending within the various ISO CLASS environments,
Is microbial identification still required,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

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Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>

 

 

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