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

Why Should You Attend:

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.

This webinar will cover the basics on how to maintain a good design history file that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to take to ensure that the DHF is completed as the design and development process progresses. Additionally, 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.

Areas Covered in the Webinar:

• 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.

Who Will Benefit:

This webinar will provide valuable assistance to medical device companies in managing their Design History Files. The employees who will benefit include:

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

Mercedes Massana
Founder & CEO, MDM Engineering Consultants

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 twenty-five 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: 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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