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Date: 9th February, 2010

Location: On-Line, North America

Summary:
Pharmaceutical - Web Seminar

Click here to Register for this Seminar

The objective of this live and interactive BenAstrum web training course 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 Micro-organisms, methodology and how it impacts the typical cGMP microbiological laboratory.

Discussion Points:

• Establishing microbiological analytical procedures based on process/product requirements
  


• Developing acceptance criteria for products, components and processes
  


• The long used historic method USP <61>
  


• The new USP methods – USP <61> and USP <62>
  


• Where the methods differ from the historic method to include changes in 'Preparatory Testing'
  


• The harmonization of these methods with the comparable European Pharmacopoeia methods
  


• Alternative media used for the new USP <62>
  


• The use of phenotypic and genotypic methods for identification
  

Implementation of the New USP 61 and 62 - The Basis for USP Microbiological General Chapter Testing - Webinar