Video

Validation Protocols, Results, and Reports

As part of a presentation on US Food and Drug Administration Process Valdiation Stage 2 documentation, Paul Pluta, Ph.D., discusses the proper creation and development of validation protocols, validation results pages, and validation reports. Dr. Pluta directs the audience towards the necessary sections for each outline; the role of sampling, testing, and engineering studies; FDA recommendations for protocol development, and common validation results pages and reports problems. 

Download the validation protocol, results, and reports slides.

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