Making sure your Foreign Vendor is FDA Compliant and Stays that Way

Joy L. McElroy

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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 for major issues. Manufacturers are responsible for any vendor oversights or problems. In this webinar participants will understand how to make sure their foreign vendor is compliant and stays incompliance.

Course Objective:

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

Course Outline:

  • 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

Target Audience:

  • Regulatory affairs personnel
  • Quality assurance personnel
  • Managers and Supervisors
  • People interested  in the FDA-regulated industries
  • Auditors
Webinar Events
Live -Coming soon!

Training CD-USB

Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment

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Recorded video

Recorded video session

Premier pro price: $314 (save 10%)


Speaker: Joy L. McElroy,

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move 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 holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.


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