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, interactive 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 non-sterile product.

Learning Benefits:

• -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.

Who should attend:

• Project Managers
• Quality Assurance
• Sales
• Marketing
• Quality Control
• Manufacturing
• Validation

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people