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>>>

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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.

Learning Benefits:
-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
09:30 AM Introduction
09:40 AM Definitions,
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,
10:30 AM Break
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
  • Validation
  • Auditors

Schedule & Deliver this Live Training Webinar Privately to Your Group
 

Course Number: 221

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland


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>>>