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:
Understand regulations and expectations
Review enforcement case studies for lessons learned
Understand the Design Control Process
Identify Best Practices
Prepare a Plan for Inspection Readiness
Areas Covered in the Session:
Overview and Definitions
FDA Expectations, Regulations
Design Control Process
Design History File
Linkages to other Quality System Requirements
Lessons Learned and Enforcement Case Studies
Preparing for an FDA or NB Inspection
Who Will Benefit:
R&D Managers and Directors
Individuals participating in Product Design and Development
Individuals participating in design changes and failure investigations
Design Quality Engineers
R&D engineers and scientists
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.