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UID:2140535:Event:470022
DTSTAMP:20260416T194312Z
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.\n su
 ppliers?\nLearning Objectives:\n\nThe laws that require supplier quali
 ty audits\nWriting robust procedures for a robust supplier quality aud
 it program\nWho must conduct these audits\nWhat are the qualifications
  needed for conducting supplier audits\nHow much experience do auditor
 s need\nWill experienced auditors from another industry suffice for CG
 MP audits\nThe difficulties of scheduling audits\nRequired number of d
 ays for each audit\nDo we have to cover every single operation during 
 each and every audit\nFocus on the more important audit objectives fir
 st\nWe will learn how to adequately communicate our questions\nThe aud
 itors must ensure that all of our questions are understand and that we
  understand the answers\nDo audits need to speak every language in the
  countries where audits are conducted\n\nAreas Covered :\n\nThe qualif
 ications of a supplier quality audit\nThe contents of an adequate supp
 lier quality audit\nScheduling and planning audits\nRequired length of
  audits\nEnsuring that all of our questions are adequately conveyed an
 d understood by our suppliers\nHow to convince the 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 need secondary suppliers
  for every component we use?\n\nWho will Benefit:\n\nQuality Assurance
  and Quality Controls Managers, Supervisors and Directors\nSupply Chai
 n Personnel\nSenior Analysts in Chemistry and Microbiology and their S
 upervisors and Directors\nResearch & Development Directors (for new pr
 oducts and suppliers\n\n\nFor more information visit https://medtechiq
 .ning.com/events/building-a-vendor-qualification-program-for-fda-regul
 ated-1
DTSTART;TZID=America/New_York:20211117T100000
DTEND;TZID=America/New_York:20211118T170000
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:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9638691065?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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