This CGMP course covers the purpose and impact of CGMP protocols and regulatory compliance relevant to biopharmaceutical drug manufacturing, focusing on quality in CGMP environments.. Learners will gain an understanding of the principles of CGMP applied to product analysis as well as discovery, development, manufacturing, verification, and validation, and will explore the history of CGMPs and the role of the U.S. FDA. The course will review relevant FDA regulations at 21 CFR 210, 211, and 600.
This course would be useful for those new to CGMP environments, including engineers, project managers, quality assurance professionals, quality control managers, regulatory affairs personnel, auditors, production engineers and managers, and manufacturing management individuals who would like to apply CGMP compliance tools and techniques to their facilities.
This course is powered and delivered by CITI Program. To learn more about this course and to register, please visit the CITI Program website.
