Best Practices for an Effective Cleaning Validation Program

This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.

Cleaning validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes will be included.

Additional benefits of this class include:

• Learn not just from the director, but tap into the knowledge of your peers: Participants will have the opportunity to discuss their challenges and problems
• Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has several decades of pharmaceutical experience including cleaning & process validation, QA/QC, equipment qualification, analytical laboratory, R&D, and academic experience. He also teaches FDA the concepts of cleaning validation and serves as a subject matter expert (SME) for FDA litigation of companies through the Justice Department of the US government

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.