Design Controls are essential for producing safe and effective medical devices. Therefore, 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 virtual 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. The seminar will cover the history, context, and requirements for design controls. Discussion will include 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 provides 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.
Learning Objectives:
In this virtual seminar, 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
- FDA 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
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
- 10.00 AM: Session Start
- Session 1 (90 Mins):
- Overview and Expectations
- Background of FDA regulations
- Design Controls as an integrated part of New Product Development
- Design Planning
- Project Management
- Break
- Session 2 (90 Mins):
- Design Inputs
- Design Outputs
- Tools, forms, documents
- Break
- Session 3 (90 Mins):
- Design Verification and Validation
- Concepts
- Strategies
- Statistical techniques
- Design Verification and Validation
- Session 1 (90 Mins):
- Design Review
- Design History File
- Documentation Requirements
- Break
- Session 2 (90 Mins):
- Design Transfer
- Design for manufacturability concepts
- Design Changes
- Change Control and configuration management
- Linkages to other quality sub-systems
- Risk Management
- Failure Investigation
- CAPA
- Break
- Session 3 (90 Mins):
- Inspection Preparedness and Compliance Strategy
- Lessons Learned
- Myths
- Challenges
- Best Practices
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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Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).Cancellations and substitutions for In-person Seminars:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Cancellations and Substitutions for Virtual Seminars & Webinars:
Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice. Offers:Related Webinars
- Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR
- Software Design Controls in Life Sciences Applications
- Risk-based Design Control - The New Paradigm for Medical Device Design
- Design Control for Medical Devices: Overview and Design Inputs
- Design Control for Medical Devices Including Verification/Validation
- Learning Design Controls through review of FDA 483 Observations
