US FDA Medical Device QSR, 21 CFR 820 and Quality Management System _ eMedEvents

1. 11/10/2021, 11:57 US FDA Medical Device QSR, 21 CFR 820 and Quality Management System | eMedEvents  Introductory Offer Sign In Assistant Are you an Organizer?   Maximize CME/CE Allowance SEARCH  Advance Search ‹ › Internal Medicine/Family MedicineOncologyRadiologyPsychiatryPediatricsEmergency MedicineNeurologyCardiologyDermatologyDentists Obstetrics and Gynecology Home / Conferences / US FDA Medical Device QSR, 21 CFR 820 and Quality Management System  US FDA Medical Device QSR, 21 CFR 820 and Quality Management System  By ComplianceOnline   Live Webinar Oct 13, 2021 60 Minutes USD 199.00 REGISTER  Overview Conference Summary Specialties US FDA Medical Device QSR, 21 CFR 820 and Quality Management System is organized by ComplianceOnline and will be held on Oct 13, 2021. Who Will Bene?t: • R&D • Engineers • Software developers • QA / RA • Marketing • Manufacturing • Operations • Staff • Middle Management • Senior Management Why Should You Attend: In the U. S., the Quality System (QS) Regulation (21 CFR Part 820) governs the manufacturing of medical devices, the device CGMPs. What is the importance, and purpose, and the framework of basic requirements for design and manufacture of medical devices, as well as a summary of the key requirements, the 15 subparts, terms, and the underlying purpose for the requirements under the Device CGMPs? How is a company’s quality management system “established / implemented and maintained under this Quality Management System (QMS)? Major discussion points: Regulatory requirements that apply to the methods, facilities and controls used for device design and development, production, installation, documentation, and servicing. Also: the Quality Management System, Management Responsibility, Managing Resources, Planning, Design and Development / Control, Change Control, Purchasing, Production, and Monitoring, Analysis, and Improvement. Description: Learn the basic overview of the original medical device Quality Management System - The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT. Areas Covered in the Webinar: • What are US FDA expectations for a compliant device QSR? • How can a company develop and maintain a dual QMS. • Basic Systems / SOPs. • QSIT (FDA’s Quality System Inspection Technique) • Brief discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they ?t. • Current areas of FDA concern. Target Audience Contact Us https://www.emedevents.com/online-cme-courses/live-webinar/us-fda-medical-device-qsr-21-cfr-820-and-quality-management-system 1/3

2. 11/10/2021, 11:57 US FDA Medical Device QSR, 21 CFR 820 and Quality Management System | eMedEvents • Other US FDA device requirements. • Maintaining compliance under increasing regulatory expectations. • Similarities /differences to ISO 13485 and the MDR. Specialties Medical Education Quality Management Target Audience Pharmaceutical Companies Contact Us Toll free Number 1(800) 828-2059 Email support@eMedEvents.com Chat Assistant Live Chat Reviews Given by People No Reviews available. Be the ?rst to write a review. Add Review Recommended Conferences Medical Education Pharmacy and Medicine Live Webinar Live Webinar USD 199 USD 229 Oct 18, 2021 Oct 18, 2021 How to Conduct Successful Supplier Audits Troubleshooting Dissolution Methods for Solid Oral Dosage Forms Medical Education Pharmacy and Medicine, Medical Education Medical Education Live Webinar USD 199 Oct 19, 2021 Medical Device Software Development Under IEC 62304 Medical Education, Healthcare Technology Subscribe for Newsletter, Medical News & Blog Updates Subscribe Your Email Address No spam, ever. Your email address will only ever be used for newsletter, medical news & blog updates https://www.emedevents.com/online-cme-courses/live-webinar/us-fda-medical-device-qsr-21-cfr-820-and-quality-management-system 2/3

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