FDA Inspection and Medical Device Design Control

Duration: 60 Minutes
According to the recent FDA enforcement trends (including 2013), inadequate design control is frequently cited in 483s and FDA warning letters.
Medical Device Design Control
Instructor: David Lim
Product ID: 500300

FDA warning letters state "Failure to establish and maintain adequate procedures to control the design of the device in order to ensure specified design requirements are met, as required by 21 CFR 820.30(a)(1)." Medical device firms are subject to design control requirements.

This webinar is intended to provide guidance on understanding, interpreting, and implementing design control procedures in a way to survive an FDA inspection. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs. In particular, this webinar will address how to best prepare for an FDA inspection concerning design control using real case examples.

Understanding, interpreting, and implementing design control system requirements in a holistic manner can significantly contribute to your product quality and regulatory compliance, helping to ensure your innovative medical products to be safe and effective on a global market and saving enormous amount of your unnecessary time, efforts and investment.

In this presentation, you will get familiar with design control requirements and the FDA inspection concerning design control systems applicable to all types of medical devices including IVDs. This webinar is a must for medical device and IVD firms including anyone interested in the topics from other industry.

Why Should you Attend:
To learn and ensure a design control system is adequately implemented to survive an FDA inspection.

Objectives of the Presentation:
  • To provide an opportunity to better understand and adequately implement adequate design control procedures and to survive an FDA inspection for design control requirements.
  • Statutes and Regulations Governing Medical Devices
  • Introduction and Definitions
  • Design and Development Planning
  • Design Input and Design Output
  • Design Review
  • Design Verification And Validation
  • Design Transfer and Design Changes
  • Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)
  • FDA Inspection for Design Control
  • Common Mistakes and How to Avoid
  • How to Prepare for FDA inspection for Design Control
  • Design Control: Best Practices
  • Speaker's Recommendation and Suggestions on PASS-IT Solutions
Who can Benefit:
  • R&D
  • Quality Professionals
  • Compliance Staff and Officers
  • Regulatory Affairs
  • CEOs
  • VPs
  • Attorneys
  • Clinical Affairs
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the topic
$375
Recorded Session for one participant
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
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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:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.
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