Lewis ***** is the founder and Principal Consultant of ***** and Associates. He and his associates provide consulting services in the area of GMP and GLP compliance for pharmaceutical, medical device, and biotechnology companies. The areas of expertise provided include GMP and GLP auditing of final dosage form and API manufacturers and CRO’s, Pre-Approval Inspection preparation, Quality Systems development, compliance and GMP training, problem resolution, and DEA compliance. Lewis has over 27 years of Quality Assurance and Manufacturing experience in the pharmaceutical industry. He has worked for large, medium, and small companies in positions of increasing responsibility, including responsibility for interactions with FDA District and Headquarters personnel.