Life-Cycle Management of Analytical Procedures & Validation Parameters

In validation, certain requirements are defined by the needs for the data a laboratory generates.

Some of these may be affected by changed in the same (due to formulation changes or new manufacturing processes or new changed in composition, matrix, or impurities can make a methodology ineffective.

Good planning coupled with an analytical methodology that is flexible can avoid numerous revalidations. The criteria and assessments need to extend a methods lifetime will be covered. The use of robustness and propagation of errors will be described.

Why should you Attend: Analytical method validation is time-consuming. If every change in operations or in the analytical testing requires revalidation, much time would be spent on that rather than testing for compliance and release (the selling) of products. Life cycle management is a process design to both give acceptable results and to reduce the efforts spent on revalidation. It is endorsed by the US Food and Drug Administration, ISO, USP, and ICH. Background of the approach, how to set it up in the original validation, ongoing assessment efforts, and the method criteria to use will be covered.

Areas Covered in the Session:

• The methodology
• life cycle concept
• The key criteria to make the method more flexible
• How analytical criteria are defined and chosen

• Lab Manager
• Lab Chemist
• Quality Control