GMP-operator-in-warehouse

This course details a systematic approach to effective Supplier Quality Assurance. Through an interactive and evolving case study analysis, you will explore a best-practice six-step process for managing supplier quality. You will also review some advanced Supplier QA topics.

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Learning Objectives
  1. Locate examples of regulatory and industry guidelines for supplier management
  2. Outline a system’s approach to effective supplier qualification
  3. Understand a six-step process for managing supplier quality
  4. Identify some supplier risk factors
  5. Propose possible supplier risk ratings and evaluation criteria
  6. Outline the structure and content of a Supplier Quality Agreement
  7. Identify some points to consider when designing a reduced sampling or testing program
Topics and Content
  • Introduction
    • Welcome
    • Introduction to Supplier Quality Assurance
    • True or False?
    • Regulatory and Industry Guidance
    • GMP Requirements
    • Does Every Supplier Need the Same Level of Oversight?
    • Medical Device Requirements
  • Framework for Supplier QA
    • The Framework
    • Case Study Kick-off
    • Principle and Application
    • Initial Judgement
  • Step 1 - Planning
    • 1. Planning
    • CardiStat Product Overview
    • What Could Go Wrong?
    • Impact of Undeclared API Manufacturing-process Change
    • Impact of New or Elevated Impurity
    • Impact of Cross-contamination
    • Impact of Incorrect Shipper Dimensions
    • Impact of Late Delivery
    • Planning Summary
  • Step 2 - Selection of Potential Supplier(s)
    • 2. Selection of Potential Supplier(s)
    • Selection Criteria
    • Decide What Matters
    • API Shortlist
    • Shipper Shortlist
    • Selection Summary
  • Step 3 - Supplier Evaluation and Acceptance
    • 3. Supplier Evaluation and Acceptance
    • How Much Evidence is Enough?
    • BioSynth Evaluation Planning
    • PackRight Evaluation Planning
    • Evaluation Plan Summary
    • Communicate the Plan: BioSynth
    • Key Principle
    • BioSynth Decision
    • How to Move Forward with the API?
    • PackRight Decision
    • Evaluation and Acceptance Summary
  • Step 4 - Finalisation of Controls
    • 4. Finalisation of Controls
    • Put Controls Where They Work
    • Allocate Controls
    • Document Controls and Evidence
    • Controls Summary
  • Step 5 - Delivery, Measurement and Monitoring
    • 5.1 Delivery and Acceptance
    • The First Shipments Arrive
    • BioSynth API Delivery
    • PackRight Shipper Delivery
    • First Shipments Comparison
    • 5.2 Monitoring and Re-evaluation
    • The Dashboard Tells a Story
    • BioSynth Dashboard
    • Delivery, Measurement and Monitoring Summary
  • Step 6 - Feedback and Communication and CAPA
    • 6. Feedback and Communication and CAPA
    • A Change Was Not Disclosed!
    • A Change is Disclosed
    • Feedback and Communication and CAPA Summary
  • Risk Management
    • Risk Based Strategy
    • Risk Identification
    • Risk Analysis
    • Risk Evaluation
    • Risk Reduction and Controls
    • Risk Acceptance
    • Risk Communication
    • Match the following to the associated risk management step.
  • Supplier Agreements
    • Supplier Quality Agreement (SQA)
    • Service Level Agreement (SLA)
    • Answer the following True/False Questions
  • Certificates of Analysis and Certificates of Conformance
    • Certificates of Analysis
    • Certificate of Conformance
    • Drag each item to either CoA or CoC
  • Reduced Sampling and Testing Considerations
    • GMP Requirements for Sampling and Testing
    • Sampling Plans
    • The n plan
    • The p plan
    • The r plan
    • Reduced Testing
    • Reduced Sampling
    • Rotational Testing as part of Reduced Sampling/Testing
    • Switching Plans based on Producer Quality Levels
    • Match the Supplier to the Appropriate Inspection Level
  • Conclusion
    • FDA Warning Letters
    • Resources
Participants

The target audience for this course is personnel with Supplier QA responsibilities who are looking for a thorough training program addressing the lifecycle of vendor management with some additional advanced topics. Although focussed on pharmaceuticals, this course is also relevant to the medical device industry and offers a best practice approach for any other industry.

Assessment / Certificate

There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.

A digital credential (badge) will be issued from Credly on e-mail after the quiz assessment is passed.

Duration

The course is expected to take approximately 4 hours.

Access

For organisations looking to setup once-off or ongoing training for group of personnel, SeerPharma can create a dedicated company account in our online Learning Management System (LMS) or we can licence courses for you to host in your own LMS or QMS. Request pricing for organisations.

For individuals, you can buy for $299 (ex GST) and your licence grants you access to the course for 30 days.

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Contact us with any questions.

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