Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel 2010
September 9, 2010(Ended)Online Webinar
Laboratories that work in a GMP environment are required to have
documentation to show they are qualified to run specific, consistent
and reliable analytical test methods. Method qualification of a method
can be achieved in three ways: Validation, Verification (Compendial
Methods) and Method Transfer (company methods). Lack of such
documentation can result in warning letters from both the FDA and
Health Canada. This webinar explains the reason and purpose of USP
chapter<1226> and helps you to interpret what is required for
verification of pharmacopeia methods to satisfy regulatory
requirements. It discusses how to select appropriate analytical
performance characteristics and acceptance criteria and summarizes
documentation requirements of the verification process. The
verification process is clarified with a step by step guide with
reference to a USP monograph for an API.
Why should you attend: Are you confused with the terminology used for method qualification (verification/transfer/validation)? Have you received a 483 for not adequately qualifying a compendial method or are you at risk to receive one? Are you interested in knowing more about method verification? If you answered yes to any of the above questions or would simply like confirmation of your current approach to analytical method verification, then this webinar is for you.
Areas Covered in the Session:
- Introduction to USP Chapter <1226> Verification of Compendial Procedures
- Why verification can be more difficult than method transfer
- Determining appropriate analytical performance characteristics and setting realistic acceptance criteria
- Protocol and report
- Follow along with an example using a USP monograph.
Prices *
245 US Dollar (Early registration date: September 8, 2010)
Exhibition
No exhibition
Organization
Categories
Concurrent events
- Signal Detection and Data Mining - Webinar by GlobalCompliancePanel 2010
- Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part 11 Inspections - Webinar by GlobalCompliancePanel 2010
- ComplianceOnline Webinar - Controlling Change to meet GMP Requirements
Important
Please, check the conference website for possible changes, before you make any traveling
arrangements
* Prices are for evaluation only.
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