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Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach

This course strengthens the ability to plan, conduct, document, and follow up on supplier and vendor audits using a risk-based quality approach. Participants will improve audit consistency, strengthen manufacturing oversight, and better evaluate supplier compliance practices against documented procedures. This Course is designed for professionals responsible for supplier oversight, manufacturing quality systems, audit execution, and compliance improvement.

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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 : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3053
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Supplier and vendor audits are a critical part of maintaining control over manufacturing processes, validation activities, equipment practices, and documentation systems within regulated industries. Regulatory agencies expect organizations to evaluate whether suppliers consistently follow established procedures and maintain effective quality practices. Weak audit preparation, poor questioning methods, or inconsistent reporting can limit visibility into supplier performance and create avoidable compliance concerns.


This course addresses the operational and procedural elements required to conduct effective external audits for manufacturing facilities and suppliers. Attention is given to audit preparation, facility evaluations, auditor conduct, communication practices, observation classification, and audit reporting. The course also examines opening and closeout meetings, facility tours, handling difficult situations, and follow-up audit activities. Participants gain practical understanding of how structured supplier auditing supports quality management responsibilities, manufacturing oversight, and continuous organizational improvement.

  • Strengthen Supplier Audit Execution:

    Effective supplier audits require more than checklist completion. This course improves the ability to prepare for audits, manage facility interactions, classify observations, and document findings with greater consistency. Organizations facing increasing scrutiny over supplier controls benefit from personnel who can evaluate whether manufacturing processes and documentation practices align with established procedures.

  • Improve Audit Communication and Follow-Up:

    Audit outcomes often depend on communication quality, observation handling, and follow-up activities after the site visit. This course develops practical approaches for conducting opening and closeout meetings, managing difficult situations, and preparing clear audit reports. Participants also gain insight into certification pathways and ongoing audit program improvement supporting long-term compliance oversight.

Key Areas Covered

  • Purpose, structure, and operational importance of supplier and vendor audits
  • Fundamentals of external auditing for manufacturing facilities and quality management systems
  • Auditor conduct, communication practices, punctuality, and handling difficult audit situations
  • Audit preparation activities, planning methods, and facility evaluation procedures
  • Opening meetings, facility tours, questioning techniques, observations, and closeout meetings
  • Audit observation classification, audit report writing, and follow-up audit execution
  • Quality system oversight related to equipment, processes, validations, and documentation practices
  • ASQ Certification and ISO Certification considerations for lead auditor development

Who Must Attend

  • QA/QC Professionals
  • Senior Quality Managers
  • Regulatory Affairs Professionals
  • Quality Auditors
  • Compliance Professionals
  • Validation Departments

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

JOY MCELROY

Joy McElroy has more than 25 years of pharmaceutical and biotech industry experience supporting Quality Assurance, GMP compliance auditing, equipment qualification, cleaning validation, and technical documentation activities. Her background includes performing GMP compliance audits, batch record reviews, annual GMP training, and qualification work for multiple pharmaceutical manufacturers. She has also developed and executed validation and qualification protocols for companies including Wyeth Lederle, Merck, Catalent, Novartis, and BioMerieux, supporting practical knowledge directly relevant to supplier and vendor auditing.

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Our students love us ❤️

“Some parts we already knew, but the way it was explained made it easier to apply. We ended up revisiting our internal approach after this.”

Regulatory Affairs Manager

“Support team was quite responsive before the session. That made it easier to get aligned internally. Presenter kept things simple, not overloaded.”

Quality Assurance Specialist

“Team appreciated the clarity. Especially on a few areas we were unsure about.”



Compliance Consultant

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