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.
This session will cover:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
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...
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