The USP <62> Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
In May 2009 the United States Pharmacopeia (USP), revision 32, implemented the long awaited separation of USP General Chapter <61> Microbial Limit Tests into two new chapters, i.e., USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration, and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.
As part of these two new chapters, USP <61> and USP <62>, changes were made within the areas of sampling, quantities of final product required for testing and the media to be used for this testing. In addition, acceptance criteria have changed when recording acceptable microbiological results (limits).
USP <62> Tests for Specified Microorganisms delves into the determination of the limited occurrence or absence of specific microorganisms. It utilizes elements of USP <61> for sample preparation to include the neutralization of the product to be tested. Also discussed is the ability of the test to detect microorganisms in the presence of the product to be tested.
The monograph discusses the preparation of the test strain, how to set up the negative controls and how to examine the Growth Promotion and Inhibitory Properties of each media. USP <62> also forms the basis for many other USP General Chapter tests to include bioburden, antimicrobial effectiveness, environmental and utilities testing where tests for specified microorganisms are sought. Alternative automated and rapid microbiological test methods, which may be utilized in lieu of the USP pharmacopeial method, will also be examined and examples provided.
The objective of this live training webinar is to explore the changes to this revised USP test method, study the test for specified microorganisms’ methodology and how they impact the typical cGMP microbiological laboratory.
-Understanding the regulatory expectations for the new USP <62> and harmonized EP.
-Understand qualitative vs. quantitative testing.
-Requirements for sampling.
-Quantities of final product to test.
-Media to use for testing.
-Acceptance criteria required to meet microbiological specifications.
-Microbiological alternatives to using USP <62>.
-Improving process reliability, product safety and reliability.
-Examine how case studies may provide improvement suggestions within your organization.
Webinar outline and time breakdown:Time*
|09:15 AM||Log In Period|
|Background – Tests for Specified Microorganisms,|
|General Procedures to Include Growth Promoting and Inhibitory Properties,|
|Suitability of the Test,|
|Meeting USP <62> Requirement for Microbiological Testing,|
|10:40 AM||Meeting USP <62> Requirement for Microbiological Testing (con't),|
|Rapid Method Alternatives to Using USP <62> Requirements for Microbiological Testing,|
|Case Studies Involving Microbial Enumeration,|
|11:30 AM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
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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>>>