Quality by Design – Essential Techniques for Medical Devices 2017

8 Quality by Design - Essential Techniques for Medical Devices


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 2 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 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. 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.

Areas Covered in the Session:
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

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

Lecture 1:
• Overview and Expectations
• Background of FDA regulations
• Design Controls as an integrated part of New Product Development
Lecture 2:
• Design Planning
• Project Management
• Design Inputs
Lecture 3:
• Design Outputs
• Tools, forms, documents
Lecture 4:
• Design Verification and Validation
o Concepts
o Strategies
o Statistical techniques
Day 2 Schedule
Lecture 1:
• Design Review
• Design History File
• Documentation Requirements
Lecture 2:
• Design Transfer
• Design for manufacturability concepts
• Design Changes
• Change Control and configuration management
Lecture 3:
• Linkages to other quality sub-systems
o Risk Management
o Failure Investigation
• Inspection Preparedness and Compliance Strategy
Lecture 4:
• Lessons Learned
• Myths
• Challenges
• Best Practices

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, Worldwide Director of 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. Susa

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