This course provides an introduction to GMP for drugs and pharmaceuticals and the current U.S. FDA regulations. It reviews a brief history of GMP regulations and discusses the regulatory requirements for the quality management system, equipment, batch records, validation, packaging, labeling, holding, distribution, and audits. There are many components to the GMP regulations, and this course provides a general introduction to many of those key elements.
- Covers the foundations of the FDA regulations for manufacturing and distribution of drugs and pharmaceuticals.
- Ideal for those whose roles and responsibilities require that they understand and can apply CGMP quality principles and for those who work in a GMP-related environment and need knowledge of the regulations.
- Includes case studies and visual aids.
Quality Professionals, Production and Manufacturing Technicians, Packaging Staff, Distribution Staff, Labeling Staff, Validation Staff, Other sponsor organization representatives that contract to GMP vendors and need to understand the regulations.
Meet the Author
Susan Leister, BS, MBA, PhD, CQA, CSSBB – Technical Resources International Inc. & University of Phoenix
Dr. Susan Leister is VP of Quality and Compliance at Technical Resources International Inc., with over 20 years experience in the pharmaceutical, biotech, and medical device industries. She has a Bachelor’s Degree in Biochemistry and Molecular Biology, an MBA, a Doctorate in Organization & Management with a focus in Leadership.