BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T075710Z UID:076e0c21-d40c-46e5-b3a7-958fafcb172f DTSTART:20210629T083000 DTEND:20210630T083000 CLASS:PRIVATE DESCRIPTION:
The FDA regulates manufacturers of medical products such as devices\, pharmaceuticals\, tissue products\, and biologics. Howe ver\, the regulations don&rsquo\;t usually extent to suppliers. Instead\, the FDA expects the medical product manufacturer to implement an effective program to qualify and re-qualify suppliers for these regulated industrie s.
\n\nAn effective supplier qualification program has some specific elements including determining expectations and requirements\, identifyin g potential suppliers\, evaluating them\, selecting a supplier\, and re-ev aluating the selected suppliers. When issues arise\, the manufacturer comm unicates with the supplier and manages corrective action.
\n\nThe re sult is a supplier qualification program that address two principle questi ons:
\n\nThis workshop explains an overarching supplier qu alification program that is common to FDA regulated medical product manufa cturers. It also provides the details of the various program areas such as devices\, pharmaceuticals\, etc.
\n\nAn effective supplier qualific ation uses tools and techniques. The workshop explains particularly releva nt tools such as supplier audits\, metrics\, scorecards\, acceptance verif ication\, and corrective action. These techniques help make the program FD A compliant and robust.
\n\nAn ef fective supplier qualification program can prevent problems and save money . The goal is to ensure that competent suppliers provide products and serv ices correctly and on time. This saves cost and helps you provide good pro ducts to your customers. In addition\, an effective supplier qualification program meets the regulatory requirements\; you will not need to worry ab out an FDA 483 or a Warning Letter. This workshop provides the information you need to establish and manage an effective program.
\n \;\n\nParticipants learn the elements of an ef fective supplier qualification program for FDA regulated medical products.
\n\nDaniel O'\;Leary has more than 30 years&rsquo\; experience in quality\, operations\, and program management in regulated industries including aviation\, defense\, medical devices\, and clinical l abs. He has a Master&rsquo\;s Degree in Mathematics\, focusing on logic an d number theory. His professional experience relates to quality\, regulato ry\, reliability\, and operations management.
\n\nMr. O'\;Leary i s a regular speaker at international conferences including ASQ\, ISM\, and RAMS. He teaches courses in reliability methods\, medical device regulati ons and practices\, statistical methods\, management systems (ISO 9001\, F DA QSR\, &\; ISO 13485)\, and project management. Mr. O'\;Leary is a n ASQ certified biomedical auditor\, quality auditor\, quality engineer\, reliability engineer\, and Six Sigma black belt\; he holds an APICS certif ication in resource management.
\n\nPlease contact the event manager
Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for: \;
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