Leading Practices on Compliance Series: Quality Audits

The third webinar in the series, “Quality Audits,” addresses one of the most important sections of the Quality System Regulation (21 CFR, Part 820.22).  This section requires medical device manufacturers to “establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.” 

This webinar and its corresponding guidance document examines how best to perform quality audits in a way that is independent, thorough, and compliant with the Quality System regulation.

  WHO SHOULD PURCHASE
  Instruction is targeted to quality managers, quality auditors, regulatory/ compliance professionals, production managers, and executive management.
  QUESTIONS?
 

For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031.
  RELATED PUBLICATION
  Quality Audits: Strategy for Ensuring Effectiveness and Compliance of Quality System

SPEAKER

PROGRAM-AT-A-GLANCE

Over the course of one hour, the program addresses several challenges associated with management responsibility:

For more information on how to obtain the Leading Practices document, click here.

WEBINAR CD
Includes pdf of handout materials and webinar recording on CD. Please note that the CD will be available three weeks after the program.

WAYS TO PURCHASE

  1. Online - Buy online.
  2. Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
  3. Fax - Select and download the order form and fax to 240-396-5781.
  4. Mail - Select and download the order form and mail with payment to:

    AAMI Webinar CD Package
    Leading Practices: Quality Audits
    PO Box 0211
    Annapolis Junction, MD 20701-0211