Speaker Biography
Wayne Flaherty
Wayne Flaherty is President of Compliance Concepts International, Inc. a commissioning, validation and compliance firm. He is an electrical engineering graduate of Penn State University with 20 years of experience in engineering and validation of pharmaceutical, medical device and biotech facilities. He has extensive hands-on experience with commissioning and qualification of highly automated large scale fermentation, sterile filling and freeze drying facilities. Flaherty assisted in the development and implementation of the project execution plan for Genentech’s facility in Oceanside, California which recently was awarded the “Facility of the Year” award for project execution. He has extensive knowledge of domestic and international validation and validation management strategies for both the consulting company and production company perspectives. He has held corporate management positions in production, project management, engineering, validation and quality assurance. Flaherty has lead multiple validation inspection teams in the US and Europe and is an active Member of ISPE.