iSpeak Blog
Think of implementing a digital validation tool (DVT) as being similar to building a new house. There are decisions that need to be made before starting to build a house:
Amy Kuntzman
CAI
Principal Consultant
Amy is a Principal Consultant with CAI and member of the ISPE Paperless Validation Subcommittee, with over 20 years of pharmaceutical and biotechnology experience in the fields of Quality and Project Management. For the last several years she has concentrated on digital transformation, specifically the implementation and enhancement of integrated GxP systems to support large-scale manufacturing of pharmaceutical products. Amy has managed multiple successful cross-functional teams both as a Project Manager and as a Functional Manager, most recently focusing on helping clients implement digital validation tools at the network level and expand their existing instance to support additional sites and validation programs.
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