Creating a Good Design History File (DHF) for Audit Success
About This Event
Creating a Good Design History File (DHF) for Audit Success
Instructor: Mercedes Massana
Product ID: 501022
Areas Covered
DHF structures that work well for audits
Documents that should and should not go into a DHF
When does a DHF needs to be created
What to look for when auditing a DHF
How to address issues with the DHF
The usefulness of the DHF in continuing to maintain the product after launch
DHF ownership when third parties are involved
Why Should you Attend
This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.
A Design History File (DHF) is a requirement of QSR 21 CFR Part 820. It is a certainty that in an audit from a regulatory body, information from the DHF needs to be provided. Manufacturers would be well prepared for audits by regulatory agencies if they know the strengths and weaknesses of their DHF, and remediate as needed, prior to the agency showing up at their doorstep. Virtually every section of the design control requirements specifies information which should be found in the DHF. Manufacturers need to be aware of what gaps exist between the actual DHF and the FDA's expectation.
Objectives of the Presentation
Elements of a DHF required for compliance
When to determine if a DHF needs to be remediated
The link between traceability and a good DHF
How to update the DHF as design changes are made
How to ensure your DHF is audit ready
Possible DHF structures
Who can Benefit
R&D Engineers
Quality Engineers
Regulatory Affairs
Quality System Auditors
Project Managers
Engineering Managers and Personnel
For Registration -
http://www.onlinecompliancepanel.com/webinar/FDA-Auditing-501022/SEP-2015-ES
Note : Use coupon code 1371 and get 10% off on Registration