USFDA GMP Inspection Approach for Quality Systems

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:

  • List the six systems included in the US FDA Inspection Approach
  • Define the US FDA Inspection Approach
  • Describe the roles and responsibilities of the Quality Control Unit
  • List what is included in the Annual Product Review
  • Define verification
  • List the validation steps and describe the proper validation protocol
  • Describe the purpose of stability testing
  • Name the two primary principles of ICH Q9 and how it relates to the Quality System
  • Describe the purpose of ICH Q8 and how it relates to the Quality System
  • List the three main objectives for the implementation of the ICH Q10 model and how it supports the Quality System

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, Health / Safety / Environmental, Operations / Manufacturing, Process Control / Automation, Process Development / Technology Transfer, Project Management, Quality Assurance / Control, Regulatory / Compliance, Technical Services / Product Support, Validation / Qualification / Commissioning
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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