Design for Quality and Compliance

Why Should You Attend:

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.

Mistakes made during the design phase can cause customer dissatisfaction, compliance issues, or even harm your customers leading to MDRs and even recalls. These mistakes are sometimes difficult to correct later in the product lifecycle. It is important to understand and seamlessly incorporate design control into your product development process.

In this webinar you will hear from an industry expert on how to create an effective, efficient, and compliant design control process. Learn how to design quality and compliance into your medical device products.

Learning Objectives:

• Understand regulations and expectations
• Review enforcement case studies for lessons learned
• Understand the Design Control Process
• Understand the expectations of “risk analysis”
• Identify best practices and tools
• Prepare a Plan for Inspection Readiness

Areas Covered in the Webinar:

• Overview and Definitions
• FDA Expectations, Regulations
• Design Control Process
• Design and Development Planning
• Design Inputs
• Design Outputs
• Verification
• Validation
• Risk Analysis (Management)
• Design Review
• Design Transfer
• Design Changes
• Design History File
• Linkages to other quality system regulations and requirements
• Lessons Learned and Enforcement Case Studies
• Best Practices
• Preparing for an FDA or NB Inspection

Who Will Benefit:

• R&D Engineers and Scientists
• R&D Managers and Directors
• Product Development Managers
• Product Development Project Leaders
• Individuals participating in Product Design and Development
• Individuals participating in design changes and failure investigations
• Regulatory Affairs
• Quality Engineers
• Design Quality Engineers
• CAPA Specialists
• 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.

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