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

Duration: 75 Minutes
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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.
DHF Control Audit
Instructor: Mercedes Massana
Product ID: 506030
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
Who will Benefit
  • 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
$375
Recorded Session for one participant
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over thirty years of experience in the Medical Device industry; Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Systems Engineering, Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.
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