How to Make Sure Your Foreign Vendors are FDA Compliant and Stay that Way

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Mar 29, 2018
90 minutes
Product Description

Ensure Your Foreign Vendor is FDA Compliant – Conduct Vendor Audits, Monitor, and Use Checklists

Vendor selection is a serious process. Manufacturers are responsible for compliance from 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 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.

Join this session, where pharmaceutical and biotech expert Joy McElroy will discuss how to make sure your foreign vendor is compliant and stays in compliance. This session will give information on auditing foreign vendors for FDA compliance. It will discuss initiating audits, planning and preparing vendor audits, as well as, monitoring foreign vendor compliance.

This session will provide FDA guidance on foreign vendor expectations, what to do, and what not to do upon selecting a foreign vendor. It will also provide audit formats and checklists for ensuring a foreign vendor is qualified.

Session Highlights

This session will cover:

  • Vendor qualification and vendor disqualifications
  • Key components necessary in selecting the appropriate vendor
  • Successful vendor-client relationships
  • Appropriate vendor-client interactions
  • Conducting an on-site audit
  • Auditing for GMP compliance
  • Key documentation requirements

Who Should Attend

  • Regulatory affairs personnel
  • Quality assurance personnel
  • Managers and supervisors
  • People interested in the FDA-regulated industries
  • Auditors

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Joy McElroy

Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing environmental monitoring and sterility testing after earning a degree in zoology at North Carolina State University. She moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.  In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and...   More Info
More Events By The Speaker

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