This program will explain the regulation, show you how to characterize your product to determine which GMP category it is in , and show you what is required for compliance.
Why should you Attend: The rules at 21 CFR 4 are effective, which means that inspectors are using these rules to determine whether your combination product is adulterated and/or (in the case of expiration dates) mislabeled. From a 2014 warning letter: "In addition, please be advised that as a combination product manufacturer, you are subject to the requirements in 21 CFR Part 4, Current Good Manufacturing Practice Requirements for Combination Products, effective July 22, 2013. For example, you are required to have DHF's for your combination products under 21 CFR 820.30(j). See 21 CFR 4.4(b)(1)(ii). " Many combination products can successfully separate device and drug requirements because their manufacturing processes are completely separate for either component. However, other types of combination products require a merging of drug and device, CGMP with QSR, and there has been no new guidance to make the regulation any clearer.
Areas Covered in the Session: