USFDA GMP Inspection Approach for Production Systems

This highly interactive pre-recorded online course reviews the Production System and its importance within the USFDA Systems Inspection Approach. The course discusses the manufacturing production and process control activities and procedural and documentation requirements, examines validation processes and reviews production personnel work responsibilities, including legal requirements of training for production personnel. At the conclusion of this session, participants will be able to:

  • Describe the manufacturing production requirements
  • Identify process control activities
  • Describe the procedural and documentation requirements
  • Identify the validation processes
  • Describe the production personnel work responsibilities, including legal requirement of training for production personnel

Attendance suggested for:

  • Professionals who are new to the industry or have new work assignments that need to gain knowledge about the industry, its challenges, and regulations.
  • Professionals with industry experience that want a refresher.
  • Suppliers and service providers to the industry, who design, construct, validate and finance facilities.
  • Individuals who support the industry through training, marketing, economic development and personnel placement.
  • Individuals with responsibility for: Clinical / Investigational Products, Operations / Manufacturing, Quality Assurance / Control, Regulatory / Compliance
Dr. James C. Gerner
Senior Consultant
Corporate Management Svcs

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.

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