This highly-interactive, online course reviews the quality system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. Quality system elements reviewed include annual product reviews, complaint files, discrepancies and failure investigations, change control, reprocessing, returns/salvages, stability testing, quarantine systems, and validation/verification. Additional topics covered include how the International Conference on Harmonization (ICH) documents Q8, Q9 and Q10 relate to and support the quality system. This course is designed to provide broad, fundamental industry knowledge through a customized learning experience for individuals that want to expand their cGMP knowledge. At the conclusion of this session, participants will be able to:
Attendance suggested for:
James C. Gerner, Ed.D, M.S., M.T. (ASCP). Dr. Gerner is qualified by sixteen years of experience as an independent consultant in the Food, Pharmaceutical, Biotech, Biopharm, Clinical Research Organization, IVD firms, Compressed Medical Gas, Blood and Medical Device Industries, 14 years in the pharmaceutical manufacturing environment, 6 years of hospital laboratory experience, 11 years of management experience, and 2 years of experience teaching in the Biological Sciences Department at a University and a local college. James is a registered Medical Technologist - M. T. (ASCP), and his education includes a B.A. in Medical Technology, M.S. in Curriculum and Instruction and an M.S. in Clinical Microbiology, and a doctorate degree, Ed.D., in Corporate Training and Development. Dr. Gerner has experience and expertise in the areas of cGMP training and auditing. He has designed, developed, implemented and evaluated GMP programs for upper management, middle management, operators, maintenance, warehouse and distribution personnel, engineers, quality assurance personnel and support departments. Dr. Gerner has conducted GLP and GCP training and laboratory training for chemists, scientists, analysts and laboratory technicians. Dr. Gerner has conducted many training needs assessments and has worked with companies to develop their compliance training systems. He has also worked with companies to develop and implement their Quality System and has provided them with training and expertise on SOP writing and targeted GMP training. Another area of expertise is working with companies to implement Job Competency Models and Job Certification Programs.