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What is ECA Process Validation Workshop 2015 about?

This two-day course will focus on new FDA and EU guidelines for process validation in light of revised Annex 15 and FDA requirements. It will discuss the new lifecycle approach to process validation, including process design, process qualification, and continued process verification. Speakers will provide industry perspectives and practical case studies. Topics will include design of experiments, process capabilities, critical process parameters, statistics, and implementing the new guidelines. The target a

Author

Bruno Debonnet

Language

EN