This highly interactive pre-recorded online course reviews the Facilities and Equipment Systems and their importance within the USFDA Systems Inspection. The Facilities System elements examine the general regulations regarding facility design, maintenance, and construction; minimizing risks and preventing cross-contamination to protect the quality of the product. Review the design elements and process controls which permit effective cleaning and maintenance, minimize the build-up of dirt and dust, and prevent quality defects. The Equipment System elements reviewed include general requirements for equipment and equipment design, usage and storage; the regulations that cover the purpose, methods and procedures for equipment cleaning and sanitation; change control; equipment log book requirements and exceptions covered in the GMP regulations; calibration and maintenance, and the importance of training and recognizing the GMP training requirements.
The course includes pre- and post-assessments, a downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all Web links discussed. At the conclusion of this session, participants will be able to explain equipment verification, usage, and storage requirements:
- Identify what authority regarding equipment is provided to pharmaceutical companies in the GMP regulations
- Describe what the acronyms WASP and COP stand for
- Identify the purpose of equipment cleaning and sanitation and GMP logbook requirements
- Recognize the GMP calibration requirements
- Explain the GMP preventive maintenance requirements
- List the three types of Change Control
- Identify the GMP training requirements
- Identify the general regulations regarding facility design, construction, and maintenance
- Describe how location, design, and construction contribute to the quality of the product
- Name the external factors that can impact your facility design
- Describe the procedures and controls designed to ensure product quality
- List the methods used to prevent cross-contamination
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.