Effective Risk-Based Applications of Drug cGMPs and Validation Requirements of Cosmetics and OTC Drug Products

This cGMP training course provides the tools for risk-based implementation and continuous compliance with drug cGMPs for OTC drug product manufacturers, including cosmetic manufacturers that also produce OTC drug products. The course also covers regulatory expectations as contained in U.S. and International guidelines. This training prepares attendees to assess their current compliance status, develop strategies and plans for remediation of identified gaps and execute a plan to achieve compliance by initially addressing higher risk items within a reasonable time frame.

Attendees are given the opportunity to apply what they have learned during two workshops. In addition, ample time will be provided to address specific problems and questions of individual participants. Individuals will also have the opportunity for one-on-one consulting with the Course Director during course breaks and in the evenings

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.