Creating a Good Design History File (DHF) for Audit Success 2013

Topics

• Documents that should and should not go into a DHF
• DHF structures that work well for audits
• What to look for when auditing a DHF
• When does a DHF need to be created
• The usefulness of the DHF in continuing to maintain the product after launch
• How to address issues with the DHF
• DHF ownership when third parties are involved

Who should Attend

• Quality Engineers
• R&D Engineers
• Quality System auditors
• Regulatory Affairs
• Engineering managers and personnel