BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240319T113336Z UID:4179b02f-60f7-4f78-ba8b-bf6e2cb2089e DTSTART:20211112T090000 DTEND:20211113T090000 CLASS:PRIVATE DESCRIPTION:
< br />\nDesign Controls are essential for producing safe and effective medi cal devices. And Design Controls are considered a critical process by the FDA. Yet\, Design Controls are still one of the most frequent areas for 48 3 and Warning Letter observations. This two-day seminar will help you unde rstand\, develop\, and implement Design Controls processes and tools that are a competitive strength for your company. You will learn how to incorpo rate Design Controls into your product development process to help streaml ine development and ensure Quality and compliance.
\n\nIn this semin ar\, we will cover Design Controls for medical devices. We will understand the requirements for Design Controls and how to translate them into an ef ficient and effective process for your company. We'\;ll cover the histo ry\, context\, and requirements for Design Controls. Then we'\;ll discu ss requirements and tools in detail and include exercises to help you prac tice and improve your Design Control process.
\n\nThe intrinsic quality\, safety\, and effectiveness of medical devices are established during the design ph ase. Yet\, statistics show that a significant percentage of all medical de vice recalls are due to design problems. And those design problems can hav e disastrous results for your customer and for your company. A rigorous an d efficient Design Control process can help avoid these quality and compli ance problems. Issues that are identified early are more easily and quickl y resolved. This seminar will help you avoid design problems and their imp act on Quality\, cost\, speed to market\, and customer satisfaction.
\n \nDesign Control is one of the critical areas covered by the FDA in ins pections of medical device companies. Design issues can also result in com plaints from your customers and in medical device reports. Design issues c an even create issues with manufacturability for your company including lo w yields and excessive scrap and rework. Finding and fixing issues early o n in design provide much more leverage than trying to fix problems for pro ducts already in production. This webinar can help you learn from past iss ues and improve your next generations of product.
\n\nUsing interactive discussion a nd exercises\, students will understand the regulations\, context\, and hi story of Design Controls. They will learn how to use Design Control as a t ool to ensure product quality while meeting business needs for speed to ma rket. They will come away with key concepts\, practice in these concepts\, and extensive course notes for future use and reference:
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\nAGENDA
Overview and Expectations
\nBackground of FDA regulations<
br />\nDesign Controls as an \;integrated part \;of New P
roduct Development
Design Planning
\nProject Management
\nDesign Inputs<
/p>\n\n
Design O
utputs
\nTools\, forms\, documents
Design Verification and Validation
\n\nDesign Review
\
nDesign History File
\nDocumentation Requirements
Design Transfer
\nDesi
gn for manufacturability concepts
\nDesign Changes
\nChange Cont
rol and configuration management
Linkages to other quality sub-systems
\n\nInspection Preparedness and Compliance Strategy
\n\nLessons Learned
\nMyths
\nChallenges
\nBest Practices
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Susanne Manz\,MBA\, MBB\, RAC\, CQA is a n accomplished leader in the medical device industry with emphasis on qual ity\, compliance\, and Six Sigma. She has an extensive background in quali ty and compliance for medical devices from new product development\, to op erations\, to post-market activities. While at industry leaders like GE\, J&\;J\, and Medtronic\, Susanne worked in various world-wide roles incl uding Executive Business Consultant\, Worldwide Director of Quality Engine ering\, Design Quality\, and Director of Corporate Compliance. She has tra veled extensively throughout the world conducting audits and helping compa nies to understand and improve their Quality Management Systems. Susanne i s 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 Bel t certifications while at Johnson and Johnson. Susanne also holds Regulato ry Affairs Certification (RAC) from RAPS and is a Certified Quality Audito r 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\, M anz Consulting LLC\, with a mission to provide services to help medical de vice companies achieve world-class quality and compliance.
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\nPlease contact the event manager Marilyn (marilyn.b.turner(at)nyeventsl
ist.com ) below for:
\n- Multiple participant discounts
\n- Pric
e quotations or visa invitation letters
\n- Payment by alternate chan
nels (PayPal\, check\, Western Union\, wire transfers etc)
\n- Event
sponsorship
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\nNO REFUNDS ALLOWED ON REGISTRATIONS
\nPric
es may go up any time. Service fees included in pricing.
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