This course is intended to provide students with principles and practical implications of GMP in the pharmaceutical and biopharmaceutical industry. The issues surrounding the importance of accurate documentation, quality systems, and validation of processes will be discussed in details. The design of a proper quality control/assurance system to ensure R&D, manufacturing and marketing of safe pharmaceutical products as well as regulatory requirements will be described. Students will gain significant hands on experience with in all GMP systems, from R&D stage to product launch and sales.
This course provides a thorough foundation for Good Laboratory Practices. Students will learn the history of GLPs and how compliance will improve overall quality. Each subpart of regulatory requirement will be examined thoroughly.