This webinar is a must attend for those personnel that require an understanding of the regulation governing FDA’s Medical Device manufacturing operations. FDA’s regulates the manufacture of Medical Devices under the Quality System Regulation (QSR) 21 CFR Part 820. This is the FDA Medical Device GMP.
FDA regulates the manufacture of finished Medical Device products in the USA under a regulation called the Quality System Regulation (QSR). This QSR is the Medical Device Good Manufacturing Practices requirements in the USA. This webinar will address the reasoning for and requirements of the QSR. Every section of the QSR (Subparts A – Subpart O) will be reviewed and discussed. FDA’s “umbrella” approach to the QSR will be discussed and FDA interpretations of the QSR reviewed. This webinar will provide an understanding of the intent and expectations of FDA relative to the QSR.
Areas to be Covered:
Understanding of the QSR
Review of all subparts of the QSR (Subpart A-Subpart O)
Interpretation of the QSR
Understanding of FDA’s “umbrella” approach to the Medical Device GMP
Who will Benefit:
Regulatory Affairs Personnel
Clinical Research Associates
Personnel who require a general understanding of the FDA’s Medical Device GMP regulation – 21CFR Part 820