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.
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.
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.
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.
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.
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.
will be held in Fremont,United States on date 2015-03-03