PTI - international

Course Description

Annual Product Reviews not only are required by GMP but also can be a robust quality improvement tool if utilized properly.  The FDA's requirements for APRs are outlined in 21 CFR 211.180(e), yet this regulation is unclear regarding the quality and quantity of data that must be included in an APR.  This course examines FDA requirements and provides insight into inspectors' unwritten expectations.  Through lecture and group discussions, there exist opportunities to benchmark your APR process against those of other industry professionals. Topics include SOPs; statistical analysis; how to streamline your APR process; documentation; revalidation and change control; EU requirements for Product Quality Reviews; and more.  As an added bonus, this course also covers how to write Annual Reports (ARs) to meet NDA requirements and examines the link between APRs and ARs.  Participants learn industry best practices and return to their jobs prepared to both conduct APRs and write ARs.