FDA Quality System Regulation, 21 CFR 820 and How It Relates To ISO 9000 13485

Event Information
Product Format
Prerecorded Event
Conference Date
Fri, Jan 12, 2018
60 minutes
Product Description

Understand the FDA Quality System Regulation, 21 CFR 820 and How It Relates To ISO 9000 13485

The FDA’s Quality System regulation constitutes the same “umbrella” approach to the CGMP regulation that was the base of the original CGMP regulation. The QS regulation applies to many different types of devices, and does not elaborate how a specific device needs to be produced by a manufacturer. Instead, the regulation prescribes a framework that every manufacturer must follow and requires that manufacturers create and follow procedures and fill in the details that are suitable to a given device according to the current state-of-the-art manufacturing for that specific device, and meet the requirements of 21 CFR 820.

In this session, expert speaker Joy McElroy will discuss the history of the QS regulation and its introduction. Upon attending this session, you will understand the basics of the Quality System regulation, 21 CFR 820 and how it relates to ISO 9000 13485. This session will cover design control guidance and the FDA’s advice on human factor and medical devices. Joy will also discuss GMP exemptions for medical devices.

Session Highlights

You will learn about:

  • Flexibility of the quality system regulation
  • Applicability of the quality system regulation
  • GMP exemptions
  • Quality system regulation preamble
  • Quality system information for certain premarket application reviews; guidance for industry and FDA staff
  • Human factors and medical devices

Session Agenda

  • General provisions
  • Quality system requirements
  • Design controls
  • Document controls
  • Purchasing controls
  • Identification and traceability
  • Production and process controls
  • Acceptance activities
  • Nonconforming product
  • Corrective and preventive action
  • Labeling and packaging controls
  • Handling, storage, distribution, and installation
  • Records
  • Servicing
  • Statistical techniques

Who Should Attend

This session will be beneficial to personnel directly involved in:

  • Development of medical devices
  • Quality control of medical devices
  • Validating equipment for medical device production
  • Working with design control and purchasing controls for medical devices
  • Process validation protocols and execution activities

This session will be beneficial for:

  • Validation and laboratory personnel
  • Beginner or seasoned operational personnel
  • Quality control and quality assurance personnel
  • Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs
  • QA and QC managers
  • QC analysis technicians
  • Disinfectant validation managers
  • Operations managers
  • Manufacturing operators
  • Cleanroom managers
  • Cleanroom operators
  • Personnel and contractors that clean and disinfect cleanrooms
  • Regulatory compliance managers and environmental monitoring managers
  • EH&S managers
  • Validation engineers and specialists

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Joy McElroy

Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing environmental monitoring and sterility testing after earning a degree in zoology at North Carolina State University. She moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.  In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and...   More Info
More Events By The Speaker

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