CfPIE Announces Advisory Board to Support Continued Life Sciences Training Alignment with Industry Regulations

Industry-active professionals converge to provide strategic guidance

Malvern, PA - March 27, 2013 - The Center for Professional Innovation and Education (CfPIE), announced today that is has formed an advisory board to support the following mission: to help life science professionals stay compliant with worldwide regulatory requirements through expert guidance, high quality training, and certification programs.



The advisory board is comprised of six CfPIE course directors:

• Michael A. Pierro a consultant leveraging 35 years of pharmaceutical industry experience to guide SOPs, study management/monitoring, auditing, and site qualification. His former roles within Sanofi-Aventis assisted the company with maintaining regulatory compliance.
• John Geigert, Ph.D., RAC, is a regulatory consultant leveraging 35+ years of CMC biological and biopharmaceutical industry experience. His former leadership roles at IDEC Pharmaceuticals, Immunex Corporation, and Cetus Corporation obtained regulatory approvals for six biopharmaceutical products, now commercially available.
• Janet Gough has extensive experience as a consultant to the pharmaceutical, biotechnology, and medical device industries. Her specialties lie in medical and technical writing, SOPs, R&D reports, regulatory submissions, and document management.
• Bill Hall, Ph.D., over the course of several decades in the pharmaceutical industry, held positions within a division of GlaxoSmithkline and the University of North Carolina at Chapel Hill. He specializes in validation, QA/QC regulations, stability programs, risk management, and GMP audits.
• Byron Larson has worked in the medical device industry since 1986, which included 15 years at COBE Laboratories and Gambro AB. Since 2001, he has been President of Toltec International, Inc., a consulting firm specializing in medical device and combination product consulting.
• Kerry Potter leverages over 30 years of experience in the pharmaceutical industry, 28 of which at Merck, bringing his expertise to bear in regulatory compliance, including quality systems audits, GMPs, documentation, project management, FDA inspections, batch record review, and root cause analysis.