Executive Conference Corporation
The mission of ECC Webinars is to provide the pharmaceutical, biotech, and medical device industries with leading edge and informative webinars led by experts in their fields, fostering a stronger knowledge base in the workforce.
"The Difference is Distictive"
Webinar
USP 61/62 Microbiological Enumeration & Examination of Non-Sterile Products
- Date: Thursday July 10, 2025
- Time: Time: 12:00 pm – 1:30 pm (NY Time)
- Instructor(s): Barry A. Friedman Ph.D
- Webinar ID#: ECC-685
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 revised
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
tests, 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 testing, environmental monitoring 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 Executive Conference Corporation webinar is
to explore the changes to these historic USP test methods,
compare them 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. Please plan to bring a
multidisciplinary group to this webinar.
By Participating in this Webinar, you will learn:
- Understanding the regulatory expectations for the new USP 61/62 and harmonized EP
- Alternatives to using USP 62 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
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance
- Quality Control
- Research & Development
- Regulatory Affairs
- Auditors
- Manufacturing
- In-Coming Materials
- Project Managers
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people