Creating a Good Design History File for Audit Success (Medical Devices Trai)
Venue: Online Event
|Event Date/Time: May 20, 2011||End Date/Time: May 20, 2011|
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 will need to be provided. Manufacturer's 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. Manufacturer's need to be aware of what gaps exists between the actual DHF and the FDA's expectation.
Areas Covered in the Seminar:
- DHF structures that work well for audits.
- Documents that should and should not go into a DHF.
- When does a DHF need 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.
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