This comprehensive training dives into the Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and discusses the regulatory requirements that impose these requirements.
Areas Covered in the Session:-
Background:-
What are the FDA and ISO requirements for Design History Files, Device Master Records, and Device History Records?
This webinar will discuss the existing requirements, how to meet and document them, and their inter-relationships.
Why Should You Attend?
Medical device manufacturers must meet different product documentation for the U.S. and the European Union. The Quality System Regulation mandates Design Control and the Design History File (DHF). ISO 13485:2016 has identical requirements under Design and Development. The Quality System Regulation mandates Device Master Record and Device History Record; similar requirements required in ISO 13485 are stated differently.
Who Will Benefit?
This 60-minute online course is intended for professionals in the Medical Device Industry.
Jeff Kasoff has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence, Regulatory Affairs Certification, Lead Internal Auditor, and Lean Black Belt.
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