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The FDA has been promoting a paradigm shift in systems compliance recently, with the goals of improving systems quality and realizing opportunities for process optimizations. CSA has been "the talk of the industry" for years, yet sometimes organizations struggle to develop expert understanding and deploy real-life practical implementations of the CSA concepts. This session will dispel the "mystery" of CSA, cover the historical factors behind the CSA publication, confirm what CSA is and what it is not, review the core principles, and provide practical steps towards CSA adoption.
Bring your questions!
Moderator:
John Niziolek; IPS
Presenter:
Paul Labas; Senior QA & CSV Leader
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