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

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Online Compliance Panel   

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R&D Engineers, Quality Engineers, Regulatory Affairs, Quality System Auditors, Project Managers, Engineering Managers and Personnel, Quality Managers, Production/Process Managers/Engineers, Manufacturing Managers/Engineers, QA and QC managers, inspectors, supervisors and personnel, Documentation Specialists, Supplier Quality Managers/Engineers, Regulatory Managers/Engineers

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Seminar Summary:

This webinar will cover the basics on how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit. (see full course description)

 

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Training Course Syllabus:


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

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

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.

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

Seminar Summary:

This webinar will cover the basics on how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit. (see full course description)

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