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Creating a Good Design History File (DHF) for Audit Success
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. 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. 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 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. Note: Use coupon code 232082 and get 10% off on registration. For Registration: http://www.complianceonline.com/creating-a-good-design-history-file-for-audit-success-webinar-training-701978-prdw?channel=tsnn