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SQA Inspector Roles and Responsibilities Flashcards

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  1. What is the primary professional mission of the Society of Quality Assurance (SQA)?

    Answer: To advance quality assurance in the regulated research community through education, networking, and professional development

    SQA's mission is to support QA professionals in regulated research through education, community, and professional growth.

  2. Which professional designation is offered by SQA to recognize demonstrated competency in quality assurance?

    Answer: Registered Quality Assurance Professional (RQAP-GLP)

    SQA offers the Registered Quality Assurance Professional – GLP (RQAP-GLP) credential to recognize QA professionals in nonclinical research.

  3. Under GLP, the QAU must maintain a record of all inspections performed. What must this record include?

    Answer: Date of inspection, study inspected, phase of study inspected, and name of inspector

    GLP requires inspection records to document the date, study or process inspected, phase or aspect inspected, and the QAU inspector's name.

  4. What is a key ethical requirement for a GLP quality assurance professional regarding conflicts of interest?

    Answer: The QAU must be organizationally independent of the studies it audits to avoid conflicts of interest

    GLP explicitly requires QAU independence from study conduct to prevent conflicts of interest from compromising audit objectivity.

  5. When a GLP QA professional identifies a serious noncompliance during an in-process study inspection, what is the immediate required action?

    Answer: Inform the Study Director and Test Facility Management promptly so corrective action can be taken

    Serious noncompliances must be promptly escalated to the Study Director and management so the impact can be assessed and corrected in real time.

  6. Which behavior best exemplifies professional integrity for a GLP quality assurance inspector?

    Answer: Reporting all findings accurately and completely, even when pressured to soften or omit them

    Professional integrity requires complete and accurate reporting of all findings regardless of external pressure or relationship dynamics.

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