The principles and approaches of this course apply to both bulk and secondary biotechnology manufacturing operations. Participants can expect open class discussions, sample problems, and an analysis of case studies. Throughout the course, the GMPs will be positioned as an essential tool for developing manufacturing control strategies that integrate product quality, regulatory compliance, and product performance. The course will help participants apply GMPs to their specific job responsibilities and acquire the comfort level required to interact with fellow employees concerning GMP issues.
Current good manufacturing practices (cGMPs) define acceptable standards for all aspects of biopharmaceuticals manufacture – and their proper interpretation and application is critical for meeting customer as well as regulatory expectations. This hands-on course gives participants the opportunity to stay on top of current issues and trends in the biotechnology industry, and to learn the basic requirements of the U.S. Food and Drug Administration (FDA).
With a focus on biotechnology products, the course will emphasize the rationale behind cGMPs. Participants will learn the history of the GMP regulations, the regulatory process, and the concept of operating in a state-of-control environment. The course will review GMPs as they relate to the industry and why simple statements in the GMP regulation may result in extensive control mechanisms for compliance.
In addition, the course will present information about the FDA, including how the agency enforces GMP regulations and what to expect during a routine GMP inspection. Participants wll gain valuable insight into compliance and auditing processes, and the importance of science in supporting regulatory decisions. They will also be exposed to the people side of the GMPs, the challenge of defending products against contamination, how to consistently build quality into products, and how important it is to personally audit for GMP compliance and performance. The lecture part of the course will conclude with a discussion on how to provide proof, through validation, that processes are operating properly, that the workplace is adequately designed to fit the application, and that GMPs are successfully maintained.
Case study discussions will help verify participants’ understanding of the learned concepts.
