This course is based on the 21CFR 210/211 standard, providing skills necessary to perform internal process audits in the medical device industry. The course will provide a detailed review of the standard, audit activities and techniques, required documented information, objective evidence to gather, and third-party external auditor expectations when assessing pharmaceutical quality management system compliance for certification.
Good Manufacturing Practice (GMP) Regulation establishes methods to be used, and the facilities/controls to be used for, the manufacturing, processing, and packing or holding of a drug to ensure that it is safe, has the appropriate identity and strength, and meets the quality and purity characteristics as determined by 21CFR 210/211.
Professionals in the pharmaceutical field looking to improve competency in quality compliance
None
Another session may be scheduled if there is enough demand. Contact Gary Simon at ggsimon@buffalo.edu if interested.