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

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 Minutes
Product Description

Keep Your Design Control System under Check to Be Compliant with the FDA’s Design Control Requirements

Device manufacturers are required to establish and maintain FDA-compliant quality management systems—wherever it’s appropriate and applicable— including a design control subsystem.  

In this audio session, Dr David Lim will throw light on the regulatory requirements for a medical device design control system including design history file (DHF), device history record (DHR), and device master record (DMR). David will provide practical, actionable and sustainable guidance on how to adequately implement design control requirements as a subsystem of the quality management system.  

Get familiar with design control requirements including DHF, DHR, and DMR, and learn how to adequately establish and follow design control procedures, to the extent, applicable to your device types in this 60-minute audio conference.

Areas to be covered in this session:

  • Laws and Regulations
  • Definitions
  • Design and Development Planning
  • Design Input
  • Design Output
  • Design Review
  • Insights on Design Verification And Validation including Software Validation
  • Design Transfer
  • Design Changes
  • Design History File (DHF)
  • Device History Record (DHR)
  • Device Master Record (DMR)
  • Common Pitfalls and How to Avoid
  • Enforcement Actions: Case Studies
  • Find the PASS-IT Recommendations, and the Best Practices

Who should attend:

  • R&D Scientists, Engineers, Managers, and Directors
  • Regulatory Affairs
  • Quality Professionals
  • Product Development Professionals
  • CROs
  • Consultants
  • Senior Management
  • Contractors and Subcontractors
  • Anyone interested in the subject

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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