Ginni Doshi, President & CEO
Ginni is the President & CEO of CMAC Consultancy, Inc.. Ms. Doshi has more than 17 years of experience in the pharmaceutical and biotechnology industries, specializing in the areas of pharmaceutical and medical device manufacturing, process and test method validation, FDA compliance audits, cGMP documentation systems, training programs, PLA submissions, and change control management. She has managed the planning, scheduling and resource allocation for development and implementation of a test method validation database. Ms. Doshi has reviewed and approved batch records for product release and performed compliance audits in support of manufacturing, clinical and validation lots, coordinated personnel training programs for cGMP documentation and change control. She has performed test method and process validation execution in support of IND, PLA and PMA submissions for medical device and diagnostic manufacturing. Additionally, Ms. Doshi has performed field execution for facility process validation, and implemented FDA guidelines for extraneous matter investigation in pharmaceutical solid dosage manufacturing. Ms. Doshi received her B.S. in Medical Technology and Microbiology from Rush University in Chicago, and is affiliated with PDA, ASQ, and ASCP. .

Dr. Daniel Hoch, Ph.D.
Daniel is a Vice President with Protocol Link and has over 18 years experience in the pharmaceutical and biotechnology industries. Dr. Hoch has held significant management positions in QA/QC for major pharmaceutical companies. He has expertise in process and analytical test method validation, ANDAs, CAPA system development, Annual Product Reviews, product release and recalls, product complaints, laboratory management, computer system validation, databases and stand-alone software systems. Dr. Hoch has performed cGMP and QSR compliance assessments in support of PLA and BLA submissions as well as 510K and regulatory compliance for medical device and diagnostics operations. He has performed site readiness inspections in preparation of FDA audits and has served as the on-site liaison to FDA investigators for major pharmaceutical companies. Dr. Hoch has initiated and managed OOS investigations, stability testing and cleaning validation programs. He has considerable experience involved in pharmaceutical liquid, solid and parenteral drug manufacturing and has served as the lead auditor for GMP audits of third party contract manufacturers. Dr. Hoch received his Ph.D. in Analytical Chemistry from Purdue University in Indiana and is affiliated with PDA, PDA Midwest, and ISPE.

Pierre Le Meur, Ph.D.
Pierre is a consultant with CMAC Consultancy, Inc. with more than 30 years experience in the pharmaceutical industries. Dr. Meur has considerable experience in plant and process engineering, validation management, design and engineering, process equipment, and sterilization. He has defined and implemented sterilization engineering requirements and procedures into corporate specifications to ensure compliance with cGMP requirements, and performed validation and documentation development in support of a major projects. Dr. Meur is a qualified GMP Instructor in both EU & FDA Regulations and has prepared and executed associated with quality engineering, compliance audits of API processes, global audits, protocol generation, regulatory aspects In Pharmaceutical and Chemical industry, air treatment systems validation, plant operations & process redesign and clean fluids dispatching systems. Dr. Meur received his Ph.D. in Chemical Engineering from the Institute Politecnico de Mexico M.S. degree in Engineering from E.N.S.I.G.C. Toulouse, France and his B.S. degree from the Institute of Chemical Engineers in London, U.K.

Leslie Schwartz
Leslie is a consultant with CMAC Consultancy and has over 16 years of experience in the pharmaceutical and biotechnological and medical device industry. Leslie has an extensive background in pharmaceutical quality assurance and quality control, pharmaceutical validation activities, computer validation activities, current Good Manufacturing Practices for pharmaceuticals and medical devices, pharmaceutical and medical device manufacturing and packaging, calibration activities, regulatory affairs, ASQ/ANSI statistical sampling techniques, statistical process control, documentation systems, analytical and wet chemical analysis, and technical writing. Leslie has developed validation protocol for process validation, manufacturing and packaging equipment, cleaning validation, validation of lab equipment and methods, and raw material evaluation, maintained stability program. Leslie has designed accelerated and room temperature stability studies and wrote and approved Standard Operating Procedures. Leslie has excellent oral and written communication skills. Leslie has a B.S. in Chemistry with Math minor from Valparaiso University, Valparaiso, Indiana and has completed the Basic Study Certificate program toward a Master's Degree in Pharmaceutical Quality Assurance and Regulatory Affairs from Temple University, Fort Washington, Pennsylvania, and is affiliated with ASQ and PDA.