USP <61>/<62> Microbiological Enumeration & Examination of Non-Sterile Products – Understanding the Current Standards for the New USP and Harmonized EP 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. The monographs for non-sterile products reference these test, e.g., USP <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. In addition, USP <61> and <62> form the basis for many other USP General Chapter tests to include bioburden, antimicrobial effectiveness, environmental and utilities testing. Alternative automated and rapid microbiological test methods, which may be utilized in lieu of the USP pharmacopeial method, will also be examined as part of USP <61>/<62> and examples provided. The objective of this live, interactive PharmaWebinar is to explore the changes to this historic USP test method, compare it to the new European Pharmacopoeia (EP), 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms, methodology and how it impacts the typical cGMP microbiological laboratory.
- Understanding the regulatory expectations for the new USP <61>/<62> and harmonized EP
-Alternatives to using USP <62>
-Requirements for sampling.
-Media to use for testing
-Acceptance criteria required to meet microbiological specifications
-Improving process reliability, product safety and reliability.
-Examine how case studies may provide improvement suggestions within your organization.
Webinar outline and time breakdown:
|10:15 AM||Log In Period|
|Establishing Analytical Procedures and Acceptance Limits|
|Types of Microbiological Methods|
|Meeting FDA, USP and EP Requirements for Microbiological Examination of Nonsterile Products|
|Meeting USP <61> Requirement for Microbiological Testing|
|11:40 AM||Meeting USP <61> Requirement for Microbiological Testing (con't)|
|Meeting USP <62> Requirement for Microbiological Testing|
|12:30 PM||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
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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