Global Compliance Trainings, 201,N Squirrel road, Suite 1007, Auburn Hills, Michigan United States - 48326.
24-03-2014
Webinar Description :
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. In this presentation, you will get familiar with regulatory and quality requirements for design control and CAPA systems applicable to all types of medical devices including IVDs. Objectives of the Presentation: - To provide an opportunity to better understand and adequately implement adequate design control and CAPA systems.
Areas Covered: - 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)
- Corrective and Preventive Action (CAPA)
- Root Cause Analysis
- CAPA Elements
- Speaker’s Recommendation and Suggestions on PASS-IT Solutions
Who will benefit: - Quality Professionals
- Compliance Staff and Officers
- Regulatory Affairs
- R&D
- CEOs
- VPs
- Attorneys
- Clinical Affairs
- Consultants
- Contractors/Subcontractors
- Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820
Why you should attend: - To learn and ensure you can implement adequate CAPA and design control procedures.
Instructor Profile Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). 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 seven 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, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Live Session for one participant Price: $225.00 Corporate Live Session 4 to 10 participants in single location. Price:$885.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $275.00 |
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