2013 - cGMP for Medical Devices Including In Vitro Diagnostic Medical Devices

FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…" This webinar will address the said current good manufacturing practice requirements to help you stay in conformity with 21 CFR Part 820.
Understanding cGMP requirements found at 21 CFR Part 820 can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.
This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) requirements for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the cGMP requirements of the Quality System Regulations (QSRs) found at 21 CFR Part 820, which helps assure that medical devices are safe and effective for their intended use.
This 60-min webinar will help you get familiar with the Quality System (QS) regulations and requirements that are necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMP for medical devices and IVDs).