This course is designed to provide students with various important aspects of quality assurance, cGMP, quality audit, and process validation; including regulatory and quality compliance as applied to pharmaceutical industries. The students will also be provided with in-depth knowledge in the organization and operation of the major departments of pharmaceutical companies, as well as ways of dealing with regulatory and compliance issues. Additionally, the course will provide advanced information on drug discovery & development process, including INDA, NDA & ANDA, drug master file & therapeutic equivalent codes. Other essential topics such as production & operational management, production planning & control shall be covered. In addition, various in-process quality control tests needed to assess some sterile and non-sterile products shall also be discussed. The course will also include pilot plant and scale up techniques, design, construction and operation of clean rooms as well as recent advances in packaging techniques for various pharmaceutical dosage forms, including stability & regulatory aspects of packaging.