BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:63551 DTSTAMP:20260526T114510Z SUMMARY:Supplier Quality Management: Implement it Now or Pay for it La ter DESCRIPTION:This webinar will discuss FDA's requirements for medical d evice supplier management and the controls you need to have in place t o ensure compliance with quality. It will cover how to structure a sup plier quality agreement and the tools and methods you need for evaluat ing and assessing suppliers.\n\nThis webinar will discuss FDA's requir ements for medical device supplier management and the controls you nee d to have in place to ensure compliance with quality. It will cover ho w to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.\nWhy Should You Atten d:\nFailure to adequately assess and control your supplier/subcontract or pool can result in dire consequences for an organization. Aside fro m the regulatory implications for failure to comply with FDA’s requi rements, not assessing and monitoring your suppliers can result in pro duct recalls, high levels of complaints, potential patient/user injuri es and deaths, and expensive lawsuits. Not explicitly defining the res ponsibilities of your suppliers can lead to adulterated and mis-brande d product, as well as unnecessary costs associated with cost of good a nd overhead.\nAssessing and approving your suppliers before placing th e first order with them will eliminate many headaches for a medical de vice manufacturer.\nThis webinar will provide attendees with the infor mation and tools necessary to develop, implement, and effectively util ize and maintain a program for Supplier Quality Management that will s atisfy the FDA’s requirements without creating undue burdens for the organization.\nAreas Covered in the webinar:\n\nSupplier Quality Mana gement Overview\nSupplier Selection, Approval, and Disapproval\nSuppli er Evaluation and Performance Monitoring\nSupplier Approval Status: Ap proved, Conditional, Disapproved, Probationary\nSupplier Change Contro l\nSupplier-Related Corrective and Preventive Action, Continuous Impro vement, and Development\nSupplier Quality Agreements\nSupplier Contrac t and Agreement Administration\nSupplier Records\n\nLearning Objective s:\n\nUnderstand the FDA’s requirements for medical device supplier assessment and approvals.\n“Who” are considered to be suppliers?\n How to structure a Supplier Quality Agreement\nWhat are the potential methods for evaluating and assessing suppliers?\n\nWho Will Benefit:\n This webinar will provide valuable assistance to the following departm ents of medical device manufacturers:\n\nQuality Assurance/Quality Con trol Directors, Managers, and Specialists\nRegulatory Affairs/Regulato ry Compliance Directors, Managers, and Specialists\nPurchasing/Materia ls Management Directors, Managers, and Specialists\nEngineering/Develo pment Directors, Managers, and Specialists\nDocument Control Managers and Specialists\nMedical Device Suppliers\nMedical Device Contractors, OEMs\n\n\n\nFor more information visit https://medtechiq.ning.com/eve nts/supplier-quality-management-implement-it-now-or-pay-for-it-later DTSTART;TZID=America/New_York:20140422T100000 DTEND;TZID=America/New_York:20140422T113000 CATEGORIES:medical LOCATION:Online Event WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu s/~product_id=703357?channel=medtechiq URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p roduct_id=703357?channel=medtechiq CONTACT:16506203915 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg": ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR