BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T121152Z UID:087f5f42-e994-4f39-beff-4fbaf819e2cb DTSTART:20210504T083000 DTEND:20210505T083000 CLASS:PRIVATE DESCRIPTION:
Supplier selection and management is a fundamental issue faced by med ical device manufacturers. Suppliers are critical to the performance and s afety of your device as well to your business.
\n\nNeither the FDA n or your notified body regulates suppliers (with a few exceptions). Instead \, they expect you have an effective process that ensures your suppliers p erform. The regulators hold you responsible and verify your controls throu gh inspections and audits. Consequently\, you need to understand and imple ment the regulatory requirements for supplier management. You should pass an audit or inspection without any issues.
\n\nThis course delivers the tools\, templates\, and methods to help participants implement an effe ctive\, efficient\, and compliant supplier management program.
\n\nT his two-day hands-on workshop provides a clear understanding of the underl ying principles of supplier management\, using exercises to help illustrat e the points and solidify understanding. In addition\, the course uses FDA Warning Letters to raise issues and help you learn from others. As part o f the practical implementation\, the course includes supplier evaluation a nd selection\; measuring\, monitoring\, and re-evaluation\; outsourced pro cesses\; supplier auditing techniques\; and supplier issues in management review.
\n\nThe workshop uses the Global Harmonization Task Force (G HTF) framework\, but expands it to cover other important issues and techni ques. The course includes information from the ISO 13485:2021 Handbook\, F DA&rsquo\;s QSIT\, and the MDSAP Audit Model.
\n\nMultiple exercises \, guidance documents\, tools\, and templates help you implement an effect ive program.
\n \;\n\nUpon cours e completion\, participants will:
\n\nAGENDA
\nDAY 01(8:30 AM - 4:3 0 PM)\n\nSPEAKER strong>
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\nDan O'\;LearyDaniel O'\;Leary has mor e than 30 years&rsquo\; experience in quality\, operations\, and program m anagement in regulated industries including aviation\, defense\, medical d evices\, and clinical labs. He has a Master&rsquo\;s Degree in Mathematics \, focusing on logic and number theory. His professional experience relate s to quality\, regulatory\, reliability\, and operations management.
\n \nMr. O'\;Leary is a regular speaker at international conferences in cluding ASQ\, ISM\, and RAMS. He teaches courses in reliability methods\, medical device regulations and practices\, statistical methods\, managemen t systems (ISO 9001\, FDA QSR\, &\; ISO 13485)\, and project management . Mr. O'\;Leary is an ASQ certified biomedical auditor\, quality audito r\, quality engineer\, reliability engineer\, and Six Sigma black belt\; h e holds an APICS certification in resource management.
\n\nPlease co
ntact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) be
low for: \;
\n- Multiple participant discounts \;
\n- Pr
ice quotations or visa invitation letters \;
\n- Payment by alter
nate channels (PayPal\, check\, Western Union\, wire transfers etc) \;
\n- Event sponsorship \;
\n
\nNO REFUNDS ALLOWED ON RE
GISTRATIONS \;
\nPrices may go up any time. Service fees included
in pricing. \;
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\nThis event is brought to you by: \;\nMetricStream\, Inc. - NewYorkEventsList \;
\nhttp://www.NyE
ventsList.com \;
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\n SUMMARY:Supplier Management for Medical Device Manufacturers (com) BEGIN:VALARM ACTION:DISPLAY TRIGGER:-PT1H SUMMARY:Supplier Management for Medical Device Manufacturers (com) END:VALARM END:VEVENT END:VCALENDAR