Introduction to Medical Device Quality System Regulations

In this webinar, you will get an overview of FDA’s medical device Quality System Regulation, 21 CFR Part 820.

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Introducing
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rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Mar-2021

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(PPT + Recorded Training File)

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Why Should You Attend:

You will learn FDA’s expectations for the implementation and on-going operation of an effective medical device quality system.

FDA’s medical device Quality System Regulation, 21 CFR Part 820, includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. This webinar will address these matters.

Areas Covered in the Webinar:
  • Regulatory basis
  • Quality System
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification & Traceability
  • Production & Process Controls
  • Acceptance Activities
  • Non-conforming Product
  • Corrective & Preventive Action
  • Labelling & Packaging Control
  • Handling, Storage, Distribution, & Installation
  • Records
  • Servicing
  • Statistical Techniques
Who Will Benefit:

Medical device company personnel working in production, R&D, regulatory affairs, QA, and QC.

Instructor Profile:
Paul Larocque Paul Larocque

President, Acerna Inc

Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological, and medical device consultancy, which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past years consulting, and previously in industry, Paul’s focus was FDA compliance matters.

Previously, Paul held executive positions with Pfizer, Allergan, and Teva Pharmaceuticals, all related to sterile products. He was also head of the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. He also chaired the industry committee that negotiated the sterile products chapter of the GMP regulations at Health Canada. He has provided expert sworn testimony in various legal cases.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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