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PIC/S Outsourced Activities & Supplier Management

PIC/S GMP principles for outsourced activities and supplier management, including responsibilities, supplier qualification, quality agreements, performance monitoring, change control, audits and oversight.

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Course Content

Module 1: Introduction to Outsourced GMP Activities
  • 1. What Are Outsourced Activities?
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  • 2. PIC/S Requirements for Outsourced Activities
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Module 2: Contract Giver & Contract Acceptor
  • 1. Responsibilities of the Contract Giver
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  • 2. Responsibilities of the Contract Acceptor
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Module 3: Supplier Qualification
  • 1. Why Supplier Qualification Matters
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  • 2. Supplier Assessment
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Module 4: Quality Agreements & Communication
  • 1. Quality Agreements
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  • 2. Communication Between Parties
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Module 5: Supplier Performance & Change Control
  • 1. Ongoing Supplier Monitoring
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  • 2. Supplier Change Management
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Module 6: Audits, Oversight & Inspection Readiness
  • 1. Supplier and Contractor Oversight
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  • 2. Inspection Readiness
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Final Assessment
Complete all modules to unlock final exam
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