Mr. Kerry Potter

Specialties: Manufacturing, Regulatory, Quality System

Mr. Kerry Potter

Kerry Potter gained his pharmaceutical manufacturing (API and Finished) experience during his 28-year career with Merck in Elkton, Virginia.  Kerry’s career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development.  More specifically, his responsibilities included project manager of laboratory assessment, FDA Quality Management System implementation, and site quality performance, as well as GMP training (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, and internal and external public relations.  He also served as one of Merck’s lead quality auditors.

In 2006, Kerry founded Summit Consulting, Inc. to offer a combination of business and hands-on consultation, training and mentoring services for the pharmaceutical manufacturing industry. This combination is founded on regulatory compliance; quality assurance; quality systems audits and assessments; design and presentation of regulatory training; GMP and documentation; and regulatory agency interaction and communication.  With 40-plus years of experience, Kerry serves as the principal consultant of Summit and is currently supporting clients with Quality Systems remediation efforts and GMP mentoring in the areas of pharmaceutical and API manufacturing in the U.S., Japan and Europe.

In addition to his consultation efforts, Kerry facilitates public and private on-site training seminars with the Center for Professional Innovation & Education (CfPIE) and the Parental Drug Association (PDA) on regulatory compliance topics for the pharmaceutical, medical device, human cell tissue and tobacco industries, both domestically and in Europe. He also serves as the Good Manufacturing Practices (GMP) Facility Certification Program coordinator and assessor with CfPIE.

Mr. Potter received his B.S. in Chemistry from James Madison University. He has received qualifications and certifications in quality auditing, facilitation and training – including instructional design and competency-based curricula. His past and current affiliations include ASQ, ASTD, PDA, GMP-TEA, ASPI and AQP.