USP <51> Antimicrobial Effectiveness Testing – A New 2016 Revised Chapter
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
On May 1, 2016 the United States Pharmacopeia revised USP<51> Antimicrobial Effectiveness Testing, USP 36 to permit it to become better aligned with various other USP General Chapters that were previously modified. These Chapters included USP<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests; USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms; and USP<71> Sterility Tests.
This new revision provides to the user greater clarity in preparation and use of test microorganisms, which test microorganisms should be used and when, how to perform growth promotion testing, and method suitability (bacteriostasis/fungistasis). The revision also clarifies the definition of “no increase” and method execution.
As part of this live webinar, the newly revised USP <51> will also be compared and contracted to the European Pharmacopeia, EU 5.1.3 Efficacy of Antimicrobial Preservation.
The objective of this live training webinar is to explore the role of the changes of antimicrobial effectiveness testing and assuring that manufactured product will retain its effectiveness of maintaining either low number or no microorganisms within product as prescribed by GMPs. It will review the issues regarding standardized and house microorganisms, management of Type 1 through Type 4 products and the interactions that occur between USP and EU testing. Because of the sensitivity of the antimicrobials with nonsterile product, this live training webinar is a MUST for anyone in your organization that is involved with nonsterile product.
-Understand why Antimicrobial Preservatives are often Required for Aqueous Pharmaceutical Products.
-Learn about Controls to include Growth Promotion and Method Suitability (bacteriostasis/fungistasis).
-Gain an Understanding of the Method Itself.
-Learn why USP<51> may not Meet European Pharmacopeia Standards.
-Review Case Studies of specific Warning Letters.
Webinar outline and time breakdown:Time*
|10:15 AM||Log In Period|
|Learn why Antimicrobial Preservatives are often Required for Aqueous Pharmaceutical Products,|
|Understand the Growth Promotion and Suitability of the Recovery Methods Studies,|
|Learn what Strains May be Used as Well as the Preparation of the Strains,|
|Learn about the Four Product Categories,|
|11:40 AM||Determine the Concentration of Each Microorganism and Its Conditions for Growth,|
|Learn of the Criteria for Antimicrobial Effectiveness,|
|A Comparison of the Proposed USP Revised Method vs. the Current EU Method,|
|Warning Letters –Examples of Non-Conformance,|
|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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