Patterson Shafer

Managing Director, FTI Consulting

Patterson Shafer has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of quality and compliance, regulatory affairs and operations, clinical, safety and surveillance, manufacturing, supply chain, medical affairs and commercial.

Pat has extensive knowledge and experience with post-market surveillance and field actions, including recall readiness. His work in that area includes identifying technology solutions to detect quality and safety signals, reengineered pharmacovigilance, complaint, CAPA and field action (recall) processes, and redesigned medical review organizations to advance compliance, safety, and operational efficiency. He has written recall best practices playbooks, published articles, and presented at multiple conferences on the subject, in addition to overseeing multiple recalls for medical device companies.