Sean Develin

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Computer Systems Validation

With over 12 years of experience in regulated industry including the pharmaceutical and financial fields, Sean Develin is currently the Manager of Validation Solutions for Falcon Consulting Group, where his practice is centered around delivering Validation, 21 CFR 11, and IT Security
consulting services to Pharmaceutical and Health Care clients worldwide. Prior to joining Falcon, he served as senior business analyst and validation consultant to Wyeth, RPR, Purdue, Amgen, Merck, Bristol-Myers Squibb, and Omnicare, focusing on business process reengineering, systems acquisition and development, and regulatory compliance. His experience in validation ranges from clinical systems to robotics, and his work has been extensively audited by both regulatory agencies and study sponsors. He studied at Villanova (BA 1988, MA in Philosophy 1993), Cornell, and at Temple (QA/RA) and is a published freelance writer.

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