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:471210 DTSTAMP:20260530T032552Z SUMMARY:Building a Vendor Qualification Program for FDA Regulated Indu stries DESCRIPTION:This course will provide detailed explanations and example s for Building a Vendor Qualification Program for FDA Regulated Indust ry. With today’s pharmaceutical market, raw materials, Active Pharma ceutical Ingredients (API), Containers & Closures, inactive or excipie nts and other components are being sourced from all over the world. We also have Third Party Manufacturers and outside testing facilities th at are part of our supply chains. Building and following a robust vend or qualification Program is essential for pharmaceutical and chemical manufacturers. We must create a procedure, which will be used to remai n aware of the compliance status for all of our suppliers. Some raw ma terial components may move from producers to brokers to the end users. In addition, there may be other shippers and wholesalers responsible for moving and holding our raw material components.\nSince, all of our components are being used to manufacture finished drug products and A PI, we must ensure the safety, efficacy and purity of these drug produ cts. Our consumers deserve to have a consistent supply of the finished drugs they use each and every day. Many of our raw material ingredien ts are manufactured globally and we are required by law (21 CFR Part 2 11.84, Testing and approval or rejection of components, drug product c ontainers, and closures) to be tested and approved before use in manuf acturing. Moreover, FDA’s Drug Supply Chain Security Act (DSCSA) req uires that we ensure the safety of drug products as they pass through the supply chain and end up in the hands od consumers. Although, Seria lization and Traceability are not being discussed during this conferen ce, our vendor qualification and continuous monitoring of our supplier s must be intermingled with our Supplier Quality Audit Programs.\nLear ning Objectives:\n\nThe laws that require supplier quality audits\nWri ting robust procedures for a robust supplier quality audit program\nWh o must conduct these audits\nWhat are the qualifications needed for co nducting supplier audits\nHow much experience do auditors need\nWill e xperienced auditors from another industry suffice for CGMP audits\nThe difficulties of scheduling audits\nRequired number of days for each a udit\nDo we have to cover every single operation during each and every audit\nFocus on the more important audit objectives first\n\nAreas Co vered :\n\nThe qualifications of a supplier quality audit\nThe content s of an adequate supplier quality audit\nScheduling and planning audit s\nRequired length of audits\nEnsuring that all of our questions are a dequately conveyed and understood by our suppliers\nHow to convince th e suppliers that our audits must be accepted and scheduled\nWhat do we do if the suppliers require us to pay a fee to audit them?\nDo we nee d secondary suppliers for every component we use?\nLearning how to dea l with the difficulties of obtaining Travel Visas\n\nWho will Benefit: \n\nQuality Assurance and Quality Controls Managers, Supervisors and D irectors\nSupply Chain Personnel\nSenior Analysts in Chemistry and Mic robiology and their Supervisors and Directors\nResearch & Development Directors (for new products and suppliers\n\n\n\n\n\n\nFor more inform ation visit https://medtechiq.ning.com/events/building-a-vendor-qualif ication-program-for-fda-regulated-3 DTSTART;TZID=America/New_York:20220216T100000 DTEND;TZID=America/New_York:20220217T170000 CATEGORIES:seminae LOCATION:online WEBSITE:https://www.complianceonline.com/vendor-qualification-program- for-fda-regulated-industries-requirements-seminar-training-80162SEM-pr dsm?channel=MedTech%20I.Q URL:https://www.complianceonline.com/vendor-qualification-program-for- fda-regulated-industries-requirements-seminar-training-80162SEM-prdsm? channel=MedTech%20I.Q CONTACT:8887172436 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0 /file/get/9948007272?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR