Good Manufacturing Practices

Good Manufacturing Practice regulations (cGMPs) apply to pharmaceutical, biotech and medical device products regulated by FDA. This course explores the content and interpretation of the regulations, with emphasis on the necessary practices, procedures and documentation required to achieve full compliance. The course will utilize case studies to facilitate interpretation and application of regulations. The attendees will gain understanding of how knowledge of the regulations facilitates efficient and cost effective issue resolution.

The first day of the course introduces students to the Food Drug and Cosmetic Act, principles of pharmaceutical GMP regulations and navigating FDA enforcement.

The second further examines application of GMP regulations in the pharmaceutical and biotech industries, medical device quality system regulations, and review of case studies for the practical application of regulations.

The third day details the controls and process that enable effective quality management with emphasis on establishment of quality systems, management responsibilities, handling deviations and techniques for auditing and monitoring of processes to ensure ongoing compliance.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Dr. Bill Hall is President of Hall & Pharmaceutical Associates, Inc. He possesses decades of pharmaceutical experience – including over 20 years of industrial experience with Burroughs Wellcome (now Glaxo Smith Kline) in cleaning and process validation, QA/QC and R&D and 17 years spent consulting for more than 200 companies worldwide.

Dr. Hall currently specializes in cleaning and process validation, QA/QC and regulatory issues for all segments of the industry – including traditional pharmaceuticals, biopharma, APIs, diagnostics, cosmetics, and contract manufacturing/packaging facilities.

Dr. Hall also serves as an instructor, training of FDA inspectors and investigators in the area of cleaning. In addition, he also serves both the FDA and Department of Justice as subject matter expert in litigation where cleaning issues have led to public health concerns. He also has more than 10 years of academic experience at the University of North Carolina at Chapel Hill.

Beyond his expertise in cleaning validation; Dr. Hall is involved in equipment qualification, calibration programs, temperature monitoring/mapping, stability programs, QA/QC, regulatory-affairs issues, risk management, internal/external/international cGMP audits, commissioning new equipment and the start-up of manufacturing facilities. He has been a frequent speaker/chairman at both validation-centered and quality-related conferences.

Dr. Hall has received numerous honors, including a Lifetime Industry Achievement Award from the International Journal of Validation Technology and membership in the Validation Hall of Fame. He is an emeritus member of the editorial board of the Journal of Validation Technology and serves on various college boards as curricula advisor.