Leading Practices on Compliance Series: Complaint Files

The new AAMI series of leading practices on compliance provides practical guidance to medical device manufacturers on historically problematic areas of compliance with FDA’s Quality System regulation. Each document serves as an easy reference tool and spells out the requirements, provides supplemental information on the intent of the requirement, and offers real-world suggestions for how to comply with the requirement.

The fourth webinar in the series addresses the top four most frequently cited observations in FDA Warning Letters to medical device companies under Complaint Files (21 CFR, Part 820.198):

  1. Absent, incomplete, inadequate procedures, or not following procedures, including receiving, reviewing, and evaluating complaints by a formally designated unit, 820.198(a);
  2. Inadequate or incomplete failure investigations involving the possible failure of a device, labeling, or packaging to meet any of its specifications, 820.198(c);
  3. Inadequate evaluation to ensure that all complaints are evaluated for Medical Device Reporting (MDR, section 803), 820.198(a)(3); and
  4. Failure to process, investigate, and close complaints in a uniform and timely manner, 820.198(a)(1).

This webinar and its corresponding guidance document will review these FDA citations and examine how best to ensure the complaint handling process is effective and compliant with the Quality System regulation.

  WHO SHOULD PURCHASE
 

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

For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031.
   

PROGRAM OBJECTIVES   

Over the course of one hour, the program will address the FDA Warning Letter citations associated with complaint files:

SPEAKER

WEBINAR CD

WAYS TO PURCHASE

  1. Online - Coming soon.
  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
    Leading Practices on Compliance Series: Complaint Files
    PO Box 0211
    Annapolis Junction, MD 20701-0211