Implementing Adequate CAPA and Design Control Procedures

Device firms, who are intending to bring medical device products into the US market, are subject to quality system regulations.

Recent FDA enforcement trends (including 2013) reveal that both design control and Corrective and Preventive Action (CAPA) systems are critical elements to sustain FDA inspections.

Device manufacturers are required to establish and maintain FDA-compliant quality management systems, where appropriate and applicable, including design control and CAPA systems. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control and CAPA system requirements. This presentation is further intended to help you establish and maintain adequate design control and CAPA procedures for all classes of medical devices including IVDs.

Understanding, interpreting, and implementing design control and CAPA 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.

This 60-min webinar will provide great opportunities for you to get familiar with regulatory and quality requirements for design control and CAPA systems applicable to all types of medical devices including IVDs.

This webinar is intended to help you learn and ensure you can implement adequate CAPA and design control procedures. In addition, this webinar will provide an opportunity to better understand and adequately implement adequate design control and CAPA systems.

Areas Covered in the Session :
Applicable Laws and Regulations
Statutory and Regulatory Requirements
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)
Corrective and Preventive Action (CAPA)
Root Cause Analysis
CAPA Elements
Common Problems
How to Avoid Common Mistakes
Speaker’s Recommendation and Suggestions on PASS-IT Solutions

Who Will Benefit:
CEOs
VPs
Compliance Officers
Clinical Affairs (Associates, Specialists, Managers, Directors and VPs)
Regulatory Affairs (Associates, Specialists, Managers, Directors and VPs)
Quality Assurance (Associates, Specialists, Managers, Directors and VPs)
R&D (Engineers, Scientists, Managers, Directors and VPs)
CROs
Consultants
Contractors/Subcontractors

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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance