Wayne Flaherty is President of Compliance Concepts International, Inc. a Commissioning, Validation and Compliance consulting firm located in Carlsbad, CA. Flaherty received his BS in Electrical Engineering from the Pennsylvania State University. Flaherty has 25 years of experience in engineering, validation and quality assurance in the Pharmaceutical and Biologics industries. Flaherty has held management positions in Production, Project Management, Engineering, Validation and Quality Assurance. Flaherty has performed quality systems and validation audits internationally and has successfully lead multiple validation inspection teams in the US and Europe. Flaherty has extensive experience in clinical and commercial biologics manufacturing facilities. Flaherty also has extensive experience in Validation of Sterile Filling and Freeze Drying facilities. Flaherty is an active member of ISPE, a frequent speaker and is a Disposables COP Steering Committee member.