Design Control Essentials for Medical Devices
Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.
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.
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 seminar can help you learn from past issues and improve your next generations of product.
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 before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
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 from 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 FDATrainingAlert 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 FDATrainingAlert cancels the seminar, FDATrainingAlert 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.
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