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Introduction to Medical Device Quality System Regulations

Event Details

Introduction to Medical Device Quality System Regulations

Time: December 8, 2021 from 10am to 1pm
Location: online
Street: Compliance Online
City/Town: Online
Website or Map: https://www.complianceonline.…
Phone: 8887172436
Event Type: webinar
Organized By: ComplianceOnline
Latest Activity: Nov 27, 2021

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Event Description

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

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

Who Will Benefit:

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

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