Quality by Design - Essential Techniques for Medical Devices
Duration : 90 Minutes
Susanne Manz,
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. She has a BS in Biomedical Engineerin Read more
Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This webinar will help you understand, develop, and implement design controls processes and tools that are a competitive strength for your company. You will learn how to incorporate design controls into your product development process to help streamline development and ensure quality and compliance.
Course 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
Why Should You Attend:
The intrinsic quality, safety, and effectiveness of medical device are established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. Design issues can even create issues with manufacturability for your company including low yields and excessive scrap and rework. And those design problems can have disastrous results for your customer and for your company. A rigorous and efficient design control process can help avoid these quality and compliance problems. Issues that are identified early are more easily and quickly resolved. This webinar will help you avoid design problems and their impact on quality, cost, speed to market, and customer satisfaction.
Course Outline:
• Overview and Definitions
• FDA Expectations, Regulations
• Design Control Process
• Design and Development Planning
• Design Inputs
• Design Outputs
• Verification & Validation
• Risk Analysis (Management)
• Design Review & 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• R&D Engineers
• R&D Project Leaders
• 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
• Anyone new to Design Control
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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