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    PracticePMI PMP®PMI PMP Practice Exam 5Question 06
    Hard1 markMultiple Choice
    Task 1: Plan and manage project complianceregulatory compliancerisk managementpharmaceutical projectsFDA regulations

    PMP · Question 06 · Task 1: Plan and manage project compliance

    A pharmaceutical project must comply with FDA regulations. During a routine audit preparation, the project manager discovers that a team member unknowingly used a non-compliant data storage method for clinical trial information over the past month. The data integrity appears intact, but the storage method violates regulatory requirements. What should the project manager do FIRST?

    Answer options:

    A.

    Document the issue in the risk register and implement additional training for all team members

    B.

    Immediately halt the affected work and assess the full compliance impact with the regulatory team

    C.

    Report the team member to HR for not following established procedures

    D.

    Continue the work while implementing the correct storage method going forward

    How to approach this question

    In compliance scenarios, prioritize immediate containment and assessment over documentation, training, or blame. Regulatory violations require urgent response.

    Full Answer

    B.Immediately halt the affected work and assess the full compliance impact with the regulatory team✓ Correct
    Regulatory compliance violations require immediate containment to prevent further violations and comprehensive impact assessment to determine corrective actions and potential reporting requirements.

    Common mistakes

    Students often choose documentation (A) or continuing work (D), underestimating the severity and urgency required for compliance violations in regulated industries.
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