- Thu, Jun 1, 2017 05:30 AM
One Edwards Way
Latitude: 33.6982, Longitude: -117.852
Medical Device Single Audit Program (MDSAP): Hear one company’s success story in getting MDSAP certified An Industry Roundtable Discussion Things are changing fast with the release of guidelines from the FDA for the MDSAP program. Canada announced it will only allow product to be sold within its country from companies that are MDSA registered starting in 2019. To add to the pressure, there is only one auditing group currently recognized by the organization to execute the MDSAP audit. So, what can you do to pass this audit the first time? Hear from the team that successfully completed MDSAP registration at Edwards Lifesciences. They will provide insight into the current program, how to prepare for the audit, and lessons learned along the way. There will be a lengthy Q&A session at the end, so feel free to ask those burning questions. Takeaways: Understand what Medical Device Sing Audit Program (MDSAP) is Know who currently participates in MDSAP Become familiar with the MDSAP model and checklist Learn how to prepare for the MDSAP certification And where to go for more information Please bring your questions, experiences, and other commentary to make this a more valuable experience. Our Speakers: Uwe Degenhardt Uwe is currently working in the Corporate Department as Director, Quality. In this role he is overseeing external agencies inspections according to applicable standards and regulations like ISO 13485, 21 CFR 820, CMDR, MDD etc. while also performing corporate audits. Members of his department oversee the Clinical Compliance program covering 21 CFR 50, 54 & 56 and Good Laboratory Practice according to 21 CFR 58. Before joining Edwards Lifesciences 2.5 years ago, Uwe was working 17 years for one of the leading Notified Bodies, TÜV SÜD. Over the course of his career in TÜV SÜD he has held different roles as Test Engineer for Active Medical Device, Lead Auditor for various standards and regulations, 510(k) Reviewer, Quality Unit Representative, and Division Manager. Uwe holds a M.S. degree in Biomedical Engineering from Technical University Dresden, Germany. Linnette TorresLinnette is currently in her 16th year at Edwards Lifesciences, currently in the role of Quality Director for the Critical Care business unit. She is responsible for the CC product lines with an annual sales of over 500M and a business presence in 5 countries. Over the course of her 16+ years in the medical device industry, Linnette has held roles in medical device manufacturing and engineering, equipment validations, quality engineering, quality systems improvement, design control, and compliance/audit readiness. Linette holds a M.S. degree in Business Administration from Pontificia Universidad Católica Madre y Maestro, Dominican Republic. In addition, she holds a M.S. degree in Productivity and Quality Management and a B.S. degree in Industrial Engineering from Instituto Tecnológico de Santo Domingo INTEC), Dominican Republic. Linette holds a certification as ISO 13485 Lead Auditor and CQA from ASQ. She is also Six Sigma Black and Green Belt certified Kristy Pollard Kristy is currently a Sr. Specialist in Quality Compliance Auditing for Edwards Lifesciences with 10+ years of experience working in the medical device/pharma/biotech industry. Over the course of her career, she has held roles in chemical/device/pharma manufacturing, sterilization/equipment validation engineering, quality engineering, internal auditing, and CAPA investigation. Kristy holds a B.S. degree from San Diego State University in Biochemistry. She is Omnex certified Lead Auditor. Registration: Dinner & drinks will be provided. Seating is limited to the first 50 registrants so sign up soon! Registration closes at noon event day. Member Early Registration $20- / After May 24th $25 Non-member Early Registration $30- / After May 24th $35 Students Registration $15- (must show valid School ID at event registration table for entrance) Walkins $35- cash only if seating is available https://www.eventbrite.com/e/asq-scdg-event-mdsap-medical-device-single-audit-program-tickets-34333466322 Location: Edwards Lifesciences One Edwards Way, Irvine, CA 92614 For more information Contact: Tiffany Abrams at (949) 250-2882 or email firstname.lastname@example.org As volunteers in a not-for-profit professional organization ASQ Biomedical, SCDG (Southern California Discussion Group) is committed to providing low cost high value events for biomedical professionals and the local community. We are able to keep our costs low by utilizing a registration system that incurs minimal administrative overhead expenses and minimizes excess time and effort spent by our volunteers to bring you these events. Please help us continue providing low cost quality programs to you by using the system that works well for us. If you do not wish to use the registration system to preregister, you may attempt to register at the event, however seating is limited therefore entrance and/or food cannot be guaranteed. Also, due to the nature of the low pricing scheme and the registration system used, we are unable to perform refunds.