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  • Category 6.

Advanced & Emerging Therapies

IMP Oversight and Inspection Readiness for QPs and QA

Overview:

This specialist course supports QPs and QA teams working with Investigational Medicinal Products, focusing on oversight, release decisions, and inspection risk in clinical and development environments.

What’s Covered:

  • IMP regulatory expectations and practical application
  • QP oversight in clinical supply chains
  • Release and certification challenges under development timelines
  • Documentation and traceability expectations
  • Scenario‑based IMP decision‑making and escalation simulations

Duration:

1 day (virtual) or 2 days (onsite)

Post‑training AI validation:

Included for onsite/classroom delivery

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Cell and Gene Therapy Oversight for QPs and QA Teams

Overview:

Designed for QPs and QA teams developing capability in cell and gene therapies, this course addresses the unique regulatory, operational, and inspection challenges associated with advanced therapies.

What’s Covered:

  • Cell and gene therapy regulatory expectations
  • Risk‑based oversight in highly variable, patient‑specific processes
  • Data integrity and traceability challenges
  • QP and QA decision‑making in non‑traditional manufacturing models
  • Scenario‑based inspection and release simulations reflecting ATMP realities

Duration:

1 day (virtual) or 2 days (onsite)

Post‑training AI validation:

Included for onsite/classroom delivery

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  • Topics
  • IMP Oversight and Inspection Readiness for QPs and QA
  • Cell and Gene Therapy Oversight for QPs and QA Teams

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