FDA Inspection and Medical Device Design Control

According to the recent FDA enforcement trends, inadequate design control is frequently cited in 483s and FDA warning letters.

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.

Why You Should Attend:

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.

Areas Covered in the Session :

• 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 Should Attend:

• R&D Departments
• Quality Departments
• Compliance Departments
• Regulatory Affairs Departments
• CEOs
• VPs
• Attorneys
• Clinical Affairs Professionals
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the topic

Course Director: DR. DAVID LIM ‎

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.