GMP for combination products, a close look at 21 CFR Part 4 2015
conferences > Education, Training conferences > GMP for combination products, a close look at 21 CFR Part 4
3 March, 2015
Palm Beach FL , USA
Overview:
The topic is the interpretation of the regulation 21 CFR Part 4, and the 2015 guidance which are rules for design and manufacturing controls for combination products. The regulation has been causing confusion since it was finalized in 2013, and this webinar will look at the regulation in terms of its history and the current practice of the Office of Compliance at CDRH.
We will outline what is meant by the regulations, in terms of new kinds of tests and data expected during manufacture for devices, and, new Quality Systems that will have to be incorporated for drugs.. This will be a concrete examination of the consequences these regulations have on affected products, and suggestion of ways to comply without adding a lot of extra staff and increasing COGS.
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.
The topic is the interpretation of the regulation 21 CFR Part 4, and the 2015 guidance which are rules for design and manufacturing controls for combination products. The regulation has been causing confusion since it was finalized in 2013, and this webinar will look at the regulation in terms of its history and the current practice of the Office of Compliance at CDRH.
We will outline what is meant by the regulations, in terms of new kinds of tests and data expected during manufacture for devices, and, new Quality Systems that will have to be incorporated for drugs.. This will be a concrete examination of the consequences these regulations have on affected products, and suggestion of ways to comply without adding a lot of extra staff and increasing COGS.
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.
Organizer
Compliance4All
18004479407
18004479407