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  • Category 2.

Statutory and Accountable Roles

QP Decision‑Making and Judgement Boundaries

Overview:

Designed for QPs, aspiring QPs, and senior QA professionals, this course focuses on how Qualified Persons make defensible decisions under pressure.

What’s Covered:

  • Legal accountability versus operational delegation
  • Release decisions under uncertainty
  • Managing pressure while maintaining independence
  • Documenting decisions to withstand inspection scrutiny
  • Scenario‑based release decision simulations

Duration:

1 day (virtual) or 2 days (onsite)

Post‑training AI validation:

Included for onsite/classroom delivery

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RPi Oversight and Import Risk Perception

Overview:

This course builds real Responsible Person (Import) capability beyond role descriptions, focusing on assurance evidence, import oversight, and escalation thresholds.

What’s Covered:

  • Import oversight expectations in practice
  • Evidence regulators expect to see
  • Managing reliance on third‑party documentation
  • Escalation points and decision ownership
  • Scenario‑based import risk assessments

Duration:

1 day (virtual) or 2 days (onsite)

Post‑training AI validation:

Included for onsite/classroom delivery

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  • Topics
  • QP Decision‑Making and Judgement Boundaries
  • RPI Oversight and Import Risk Perception Management

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