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How to Ensure Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists

This course provides practical methods for qualifying and auditing foreign vendors while strengthening GMP oversight, vendor communication, and documentation practices. Participants will gain a structured approach for evaluating supplier suitability, identifying compliance risks, and maintaining accountable vendor relationships aligned with FDA expectations. This Course is designed for professionals responsible for supplier oversight, GMP compliance, quality documentation, and vendor qualification activities.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Joy Mcelroy
  • Study time : 75 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2558
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Foreign vendors supplying pharmaceutical and biotech manufacturers are subject to the same FDA expectations as domestic suppliers, making vendor oversight a critical compliance responsibility. Inadequate qualification, weak audit practices, or poor vendor communication can expose manufacturers to regulatory observations, product quality concerns, and accountability for supplier failures. Effective vendor assessment requires documented qualification methods, structured audit preparation, and ongoing monitoring practices that support GMP compliance.


This TalkFDA Live webinar addresses the operational and regulatory responsibilities involved in selecting, auditing, and monitoring foreign vendors. The course explains how to prepare for on-site audits, evaluate GMP compliance, document vendor performance, and apply practical audit formats and qualification checklists. It also addresses vendor-client interactions, communication expectations, and methods for establishing consistent oversight processes that support reliable supplier relationships while reducing compliance exposure linked to foreign vendor activities.

  • Build Stronger Foreign Vendor Qualification Practices:

    Participants will gain practical methods for assessing foreign vendors before approval, including qualification criteria, communication expectations, and documentation practices. The course supports more consistent supplier evaluations and helps reduce operational exposure associated with unsuitable vendors, incomplete assessments, or weak oversight processes that may create compliance concerns during FDA review activities.

  • Improve Audit Readiness and GMP Oversight:

    This course strengthens the ability to conduct organized on-site vendor audits focused on GMP compliance, audit documentation, and performance monitoring. Participants will understand how to apply audit checklists, evaluate vendor deficiencies, and establish scoring approaches that support ongoing oversight expectations while maintaining accountability for supplier-related quality and compliance responsibilities.

Key Areas Covered

  • Foreign vendor qualification criteria and causes for vendor disqualification
  • FDA expectations for selecting and monitoring foreign suppliers
  • Establishing effective vendor-client communication and working relationships
  • Preparing for and conducting foreign vendor on-site audits
  • Evaluating vendor GMP compliance during audit activities
  • Creating vendor audit formats, scoring methods, and qualification checklists
  • Documentation practices supporting supplier oversight and compliance accountability
  • Monitoring foreign vendor performance to identify and address compliance concerns

Who Must Attend

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • Vendor Management Personnel
  • Auditors

Quality training, expert insights, and answers that matter. Know your Expert

JOY MCELROY

Joy McElroy earned her degree in Zoology from North Carolina State University and has more than 25 years of pharmaceutical and biotech industry experience. Her background includes Quality Assurance, GMP compliance auditing, batch record review, validation, and technical writing across companies including Abbott Laboratories, Wyeth Lederle, Mallinckrodt, Merck, and Catalent. She has conducted GMP audits, delivered compliance training, and developed qualification and validation documentation supporting regulated manufacturing and supplier oversight activities.

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2. Your Course Hub
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3. Access course materials
The presentation handout and other materials can be downloaded inside the Course Player. You could use Discussion feature there to ask your questions.

4. Watch The Streaming and Complete your Course
The course playback will be available on the same course page. You could pause and continue or you can revisit important sections.
5. Earn Your Certificate
Complete the course and your certificate is unlocked automatically in your learning history.

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“Professional presentation with clear explanations and a logical flow from start to finish.”



Auditor

“Information was presented in a simple and structured way without unnecessary detail.”



Quality Control Department

“Clear explanations and a professional approach made the session easy to stay engaged with.”


Compliance Consultant

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