The Quality System Regulation: FDA’s Medical Device GMP



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
Q&A session

Who will Benefit:

Regulatory Affairs Personnel
Quality Personnel
Clinical Personnel
Research Personnel
Laboratory Personnel
Manufacturing Personnel
Legal Personnel
Clinical Research Associates
Personnel who require a general understanding of the FDA’s Medical Device GMP regulation – 21CFR Part 820

Albert A. Ghignone

Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements.

He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group. He is a member of the Regulatory Affairs Professionals Society which elected him the 1984 Professional of the Year. He has served the society as Vice President, President and Chairman of the Board of Directors.

In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. In addition he has been involved in two of the largest clinical trials conducted, the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.


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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance