USP <61>/<62> Microbiological Enumeration and Examination of Non-Sterile Products – Understanding the Current Standards for the Revised USP and Harmonized EP Microorganisms

Speaker

Instructor: Barry A Friedman
Product ID: 706883

Location
  • 13
  • April 2023
    Thursday
  • 08:00 AM PDT | 11:00 AM EDT
    Duration: 90 Min
The objective of this live, interactive 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.
LIVE ONLINE TRAINING

April 13, Thursday 08:00 AM PDT | 11:00 AM EDT
Duration: 90 Min

 

$199.00
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$349.00

$399.00

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training
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$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
(For multiple locations contact Customer Care)

 

 

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Read Frequently Asked Questions

Why Should You Attend:

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.

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • Quality Assurance
  • Quality Control
  • Research & Development
  • Regulatory Affairs
  • Auditors
  • Manufacturing
  • Project Managers
Instructor Profile:
Barry A. Friedman

Barry A. Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology.

From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, Quality Control, he managed a multi-shift Department of thirty one individuals involved in Client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity Dr Friedman enjoyed many client and regulatory compliance interactions.

In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, 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, TungstenShield (PharmaWebinars), IPA (Canada), Executive Conference Corp, Compliance On-Line and Pharmig (UK).

Dr. Friedman maintains an active Blog (www.barryafriedmanphdllc.com) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues as well as over 1,500 “Search” terms to assist with finding the appropriate Warning Letter and FDA 483. He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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