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Validation Boot Camp Part I | IVT

In the first half of Dawn Tavalsky's formally titled "Validation Boot Camp — A Lifecycle Approach to Pharmaceutical Validation — Principles, Implementation and Practice," Dawn Tavalsky discusses the history of good manufacturing practices (GMPs) and process validation, three case studies of GMP violoations (IV bottle contamination, hemodialysis filters, albuterol inhaler), and the basics of installation qualification, operational qualification, performance qualification, US Food and Drug Administration regulations on validation, equipment validation, process validation, facility design, and the lifecycle approach. The second half of this presentation will be published in the Journal of Validation Technology Volume 19 Number 3.

Download "Validation Boot Camp — A Lifecycle Approach to Pharmaceutical Validation — Principles, Implementation and Practice"

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