Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Susanne Manz
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.
This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. This webinar can help you create a design control process that is a competitive strength for your company.
Why should you Attend: Design Control is not only a regulatory requirement, it is a set of aligned practices that deliver a rigorous, methodical, and predictable design process leading to better product development projects and more successful products.
Without good design controls and risk management, medical device companies will experience product design problems, an unpredictable product development process, and reduced customer satisfaction.
Areas Covered in the Session:
– Overview and Definitions
– FDA Expectations, Regulations
– Design Control Process
– Design Inputs
– Design Outputs
– Design Review
– Design Transfer
– Design Changes
– Design History File
– Linkages to other Quality System Requirements
– Lessons Learned and Enforcement Case Studies
– Best Practices
– Preparing for an FDA or NB Inspection
– Understand regulations and expectations
– Review enforcement case studies for lessons learned
– Understand the Design Control Process
– Understand connection to Risk Management
– Identify Best Practices
– Prepare a Plan for Inspection Readiness
Who Will Benefit:
– R&D Engineers
– R&D Managers and Directors
– Product Development Managers
– Individuals participating in Product Design and Development
– Individuals participating in design changes and failure investigations
– Regulatory Affairs
– Design Quality Engineers
– R&D Scientists
– Compliance Specialists
– Senior Management
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, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne 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 Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.