BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T220522Z UID:3ca33a2a-0586-4f20-90c9-d55c743f1d62 DTSTART:20211112T090000 DTEND:20211113T090000 CLASS:PRIVATE DESCRIPTION:
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\n\nDesign Controls are essential for producing safe and effective medical devices. And Design Controls are con sidered 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 comp any. You will learn how to incorporate Design Controls into your product d evelopment process to help streamline development and ensure Quality and c ompliance.
\n\nIn this seminar\, we will cover Design Controls for m edical devices. We will understand the requirements for Design Controls an d how to translate them into an efficient and effective process for your c ompany. We'\;ll cover the history\, context\, and requirements for Desi gn Controls. Then we'\;ll discuss requirements and tools in detail and include exercises to help you practice and improve your Design Control pro cess.
\n\nThe intrinsic quality\, safety\, and effectiveness of medica l devices are established during the design phase. Yet\, statistics show t hat a significant percentage of all medical device recalls are due to desi gn problems. And those design problems can have disastrous results for you r customer and for your company. A rigorous and efficient Design Control p rocess can help avoid these quality and compliance problems. Issues that a re identified early are more easily and quickly resolved. This seminar wil l help you avoid design problems and their impact on Quality\, cost\, spee d to market\, and customer satisfaction.
\n\nDesign Control is one o f the critical areas covered by the FDA in inspections of medical device c ompanies. Design issues can also result in complaints from your customers and in medical device reports. Design issues can even create issues with m anufacturability for your company including low yields and excessive scrap and rework. Finding and fixing issues early on in design provide much mor e leverage than trying to fix problems for products already in production. This webinar can help you learn from past issues and improve your next ge nerations of product.
\n\nUsing interactive discussion and exercises\, s tudents will understand the regulations\, context\, and history of Design Controls. They will learn how to use Design Control as a tool to ensure pr oduct quality while meeting business needs for speed to market. They will come away with key concepts\, practice in these concepts\, and extensive c ourse notes for future use and reference:
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\n\nOverview and Expectations
\n\nBackground of FDA regulations
\n\nDesign C ontrols as an \;integrated part \;of New Product Developm ent
\nProject Management
\n\nDesign Inputs
\nDesign Outputs
\n\nTools\, forms\, documents
\nDesign Verification and Validation
\n\nDesig n Review
\n\nDesign History File
\n\nDocumentation Requirements
\nDesign Transfer
\n\nDesi gn Changes
\n\nChange Control and configuration man agement
\nLinkages to other quality sub-systems
\n\nInspection Preparedness and Compliance Strategy
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\nLecture 4 (90 Mins):\n\n
Lessons Le arned
\n\nMyths
\n\nChalleng es
\n\nBest Practices
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\n\n\nSusanne Manz
\n\nQuality and Compliance Expert / Auditor for Medical Devices \, Manz Consulting\, Inc.
\n\nSusanne Manz\,MBA\, MBB\, RAC\, CQA is an accomplished leader in the medical device in dustry with emphasis on quality\, compliance\, and Six Sigma. She has an e xtensive 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 v arious world-wide roles including Executive Business Consultant\, Worldwid e Director of Quality Engineering\, Design Quality\, and Director of Corpo rate Compliance. She has traveled extensively throughout the world conduct ing audits and helping companies to understand and improve their Quality M anagement Systems. Susanne is a Presidential Scholar and has a BS in Biome dical Engineering and an MBA from the University of NM. She earned her Bla ck Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and i s 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 establish ed a consulting business\, Manz Consulting LLC\, with a mission to provide services to help medical device companies achieve world-class quality and compliance.
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