A pharmaceutical company project must comply with FDA regulations throughout development. The project manager discovers that a team member unknowingly used a non-compliant data storage method for clinical trial information. What should the project manager do FIRST?

Answer options:

Document the compliance violation in the risk register for future reference

Immediately halt the affected work and assess the compliance impact with regulatory experts

Report the team member to HR for not following established procedures

Update the project management plan to include additional compliance training

How to approach this question

In regulated industries, compliance violations require immediate containment and expert assessment before any other actions.

Full Answer

B.Immediately halt the affected work and assess the compliance impact with regulatory experts✓ Correct

Compliance violations in regulated industries like pharmaceuticals require immediate containment to prevent further violations and expert assessment to determine the full impact and required remediation.

Common mistakes

Focusing on documentation or training before addressing the immediate compliance risk, or treating this as a personnel issue rather than a compliance issue.

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