Leading Practice on Compliance Series: Design History File (DHF): Tips for Creating a Successful DHF

The sixth webinar in this series addresses the frequently cited failure to adequately establish and maintain a design history file (DHF).  The DHF must contain or reference all the records necessary to establish compliance with the design and development plan and the design control regulation, (21 CFR Part 820.30). The DHF illustrates the history of the design, and is necessary so that manufacturers can exercise control over and be accountable for the design process, thereby maximizing the probability that the finished design conforms to the design specifications. 

This webinar and its corresponding Leading Practices publication provides examples on creating the DHF in compliance with the Quality System regulation.

  WHO SHOULD PURCHASE
 

Instruction is targeted to quality managers, quality auditors, quality assurance professionals, 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 concerns and industry best practices associated with the design history file:

SPEAKER

WEBINAR CD

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
    Leading Practices on Compliance Series: Design History File
    PO Box 0211
    Annapolis Junction, MD 20701-0211