Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR
Instructor:
Susanne Manz
Product ID: 706751
- Duration: 90 Min
Why Should You Attend:
Design Controls are an integrated set of customer focused management practices to ensure quality and consistency. A rigorous Design Control process results in more predictable product development and improved quality and compliance results. And, if you’re selling medical devices in other countries, it is important to understand the differences between Design Control requirements found in FDA 21 CFR 820.30 and the requirements of ISO13485:2016 7.3 Design and Development. This webinar can help you create a design control process that is a competitive strength for your company and meet the expectations of different regulators.
Learning Objectives:
- Understand regulations and expectations
- 21 CFR 820.3 and ISO13485:2016
- Understand the Design Control Process
- Identify key differences and solutions
- Identify Best Practices
- Prepare a Plan for Inspection Readiness
Areas Covered in the Webinar:
- Overview and Definitions
- Design Control Regulations
- Design Control Process
- Planning
- Design Inputs
- Design Outputs
- Verification
- Validation
- Design Review
- Design Transfer
- Design Changes
- Design History File
- Summary of differences between QSR and ISO13485:2016
- Linkages to other Quality System Requirements
- Lessons Learned and Enforcement Case Studies
- Best Practices
- Preparing for an FDA or NB Inspection
Who Will Benefit:
- R&D Engineers
- R&D Managers and Directors
- Individuals participating in Product Design and Development
- Individuals participating in design changes and failure investigations
- Regulatory Affairs
- Design Quality Engineers
- R&D engineers and scientists
- Compliance Specialists
- Auditors
- Senior Management
Susanne Manz
President and Principal Consultant, Manz Consulting Inc
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
