3-Hour Virtual Seminar on Ensuring Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists

Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors. Any violations from the vendors can cause serious problems for the manufacturers. Choosing a foreign vendor is no different than choosing a domestic vendor. Foreign vendors are held to the same FDA standards as domestic vendors. Manufacturers have to have an assurance that their foreign vendor is suitable. They have to know the vendor will not be the source of major issues. Manufacturers are responsible for any vendor oversights or problems. In this seminar participants will understand how to make sure their foreign and domestic vendors are compliant and stay in compliance.

Why You Should Attend:

Participants in this seminar will learn what qualifies a foreign vendor and what disqualifies a foreign vendor for providing services and goods to your facility. They will learn how to initiate audits from foreign vendors and suppliers. Participants will learn how to relate to foreign vendors, and how to speak in common terms that are familiar to the foreign vendor and/or supplier as well as the manufacturer. Participants will gain an understanding of how to conduct on-site audits for foreign vendors. They will have an understanding of how to rate foreign vendors and maintain successful foreign -client relationships.

Areas Covered:

  • Selection and Qualification documentation
  • Key components necessary in selecting the appropriate vendor
  • Successful vendor-client relationships
  • Appropriate vendor-client interactions
  • Auditing for GMP compliance
  • Audit Checklists
  • Audit / Qualification rating scale
  • Document Review

Who Should Attend:

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • Documentation Departments
  • Suppliers and Vendors Management Teams
  • Auditors

FDB3488

Joy McElroy

Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.