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About

Effective supplier and vendor qualification is essential for ensuring that outsourced products, materials, and services consistently meet GxP quality, regulatory, and business requirements. A structured, risk-based supplier management programme enables organisations to assess supplier capability, maintain ongoing oversight, manage quality risks, and demonstrate compliance with regulatory expectations throughout the supplier lifecycle.
This Supplier and Vendor Qualification and Management of Service Providers Training Course & Certification provides comprehensive knowledge of supplier identification and risk classification, due diligence, supplier evaluation, qualification processes, supplier audits, quality and technical agreements, performance monitoring, change management, requalification, outsourced activity oversight, business continuity planning, supplier disqualification, documentation requirements, and regulatory expectations for supplier lifecycle management. Upon successful completion, learners receive a certification demonstrating their understanding of supplier qualification, vendor management, and best practices for managing service providers in GxP-regulated environments.

Who Should Enrol?

  • Quality Assurance and Quality Management Professionals
  • Procurement, Purchasing, and Supply Chain Personnel
  • Supplier Quality and Vendor Management Professionals
  • Manufacturing, Production, and Operations Managers
  • Regulatory Affairs and GxP Compliance Professionals
  • Internal Auditors and Supplier Audit Teams
  • Contract and Service Provider Management Personnel
  • Anyone involved in selecting, qualifying, monitoring, or managing suppliers and outsourced service providers in regulated industries
📢 Every purchase also includes our FREE companion Supplier and Vendor Qualification and Management of Service Providers eBook, designed to help you apply principles in real-world manufacturing settings.

What you will learn

Understand the principles of supplier and vendor qualification, service provider oversight, quality risk management, and regulatory expectations within GxP-regulated industries.

Learn how to identify and classify suppliers, perform due diligence, conduct supplier audits, and evaluate quality, technical, and regulatory capabilities before qualification.

Develop knowledge of supplier approval, quality and technical agreements, performance monitoring, periodic requalification, change management, and management of outsourced activities.

Gain practical understanding of supplier performance metrics, risk-based oversight, business continuity planning, supplier disqualification, contract termination, and inspection-ready documentation.

Course Syllabus

  1. Who is a supplier or service provider?
  2. Supplier categories
  3. Why suppliers are controlled
  4. Governance responsibilities
  5. The supplier lifecycle in full

  1. Defining the requirement
  2. Identifying candidate suppliers
  3. The supplier inventory
  4. Assessing criticality and risk
  5. Risk categories
  6. Linking risk to qualification strategy

  1. The prequalification questionnaire
  2. Reputation and regulatory standing
  3. Quality and regulatory compliance
  4. Technical capability and assurance of supply
  5. Communication and data/cyber controls
  6. The preliminary decision

  1. The audit decision
  2. Audit formats
  3. Planning the audit
  4. Conducting the audit
  5. Classifying findings
  6. Assessing the CAPA response
  7. Audit limitations

  1. The qualification evidence package
  2. Qualification status options
  3. Decision governance
  4. The approved supplier list
  5. Conditional and emergency approval
  6. Onboarding the approved supplier

  1. Commercial contract vs quality agreement
  2. Agreement ownership and control
  3. Core quality-agreement sections
  4. Responsibility matrices
  5. Controlling subcontracting
  6. Maintaining the agreement

  1. The oversight model
  2. Performance indicators
  3. Managing supplier deviations
  4. Managing supplier changes
  5. Periodic review and requalification
  6. Escalating poor performance

  1. Supply-continuity risk
  2. Continuity controls
  3. Supplier suspension
  4. Disqualification
  5. Exit, transition
  6. Record retention through exit
  7. Inspection readiness

  1. 📘 Bonus: Supplier and Vendor Qualification and Management of Service Providers eBook (Free with purchase)

Course Benefits

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Free eBook

Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever

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CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay up to date with any changes to EU GMP Chapters 1 and 7, ICH Q10, Q9(R1) and Q7, the FDA quality-agreements guidance, EU GDP, ICH E6(R3) service-provider oversight, OECD GLP, GVP, ISO 13485 and the FDA QMSR, as our training courses are constantly monitored, reviewed and updated.

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Learn from Industry Experts

The course content reflects current GxP supplier-quality and outsourcing-oversight practice, so that learners can qualify and manage suppliers and service providers across the full regulated lifecycle.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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