Course "Quality by Design - Essential Techniques for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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 two-day seminar 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.
In this seminar, we will cover Design Controls for medical devices. We will understand the requirements for Design Controls and how to translate them into an efficient and effective process for your company. We'll cover the history, context, and requirements for Design Controls. Then we'll discuss requirements and tools in detail and include exercises to help you practice and improve your Design Control process.
Why you should attend:
The intrinsic quality, safety, and effectiveness of medical devices are established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. 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 seminar will help you avoid design problems and their impact on Quality, cost, speed to market, and customer satisfaction.
Design Control is one of the critical areas covered by the FDA in inspections of medical device companies. Design issues can also result in complaints from your customers and in medical device reports. Design issues can even create issues with manufacturability for your company including low yields and excessive scrap and rework. Finding and fixing issues early on in design provide much more leverage than trying to fix problems for products already in production. This webinar can help you learn from past issues and improve your next generations of product.
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Learning Objectives:
Using interactive discussion and exercises, students will understand the regulations, context, and history of Design Controls. They will learn how to use Design Control as a tool to ensure product quality while meeting business needs for speed to market. They will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference:
• Expectations
• Regulations and History
• Design Control process, procedures, forms, records, files
• Linkages to the rest of your Quality Management System
• Lessons Learned
• Myths
• Challenges
• Best Practices
• Inspection Readiness
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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
Agenda:
Day 1 Schedule
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Lecture 1 (90 Mins):
Overview and Expectations
Background of FDA regulations
Design Controls as an integrated part of New Product Development
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Lecture 2 (90 Mins):
Design Planning
Project Management
Design Inputs
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Lecture 3 (90 Mins):
Design Outputs
Tools, forms, documents
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Lecture 4 (90 Mins):
Design Verification and Validation
• Concepts
• Strategies
• Statistical techniques
Day 2 Schedule
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Lecture 1 (90 Mins):
Design Review
Design History File
Documentation Requirements
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Lecture 2 (90 Mins):
Design Transfer
Design for manufacturability concepts
Design Changes
Change Control and configuration management
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Lecture 3 (90 Mins):
Linkages to other quality sub-systems
• Risk Management
• Failure Investigation
• CAPA
Inspection Preparedness and Compliance Strategy
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Lecture 4 (90 Mins):
Lessons Learned
Myths
Challenges
Best Practices
Speaker
Susanne Manz
Quality and Compliance Expert / Auditor for Medical Devices, 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 industry leaders like 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 conducting audits and helping companies to 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.
