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SQA Inspector Roles and Responsibilities Flashcards

6 cards from real SQA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 SQA Inspector Roles and Responsibilities flashcards as text

  1. Which skill is most critical for a QA inspector when reviewing laboratory raw data for GLP compliance?

    Answer: Attention to detail and the ability to identify missing, altered, or inconsistent entries

    Meticulous attention to detail is the core skill for data integrity review, enabling detection of gaps, alterations, and inconsistencies.

  2. What is the purpose of the SQA-GLP Symposium held annually in the United States?

    Answer: To provide professional development, regulatory updates, and networking for GLP quality assurance professionals

    The SQA Annual Symposium is the primary professional development event for GLP QA professionals in the US, covering regulatory updates and best practices.

  3. Under GLP, which statement correctly describes the relationship between the QAU and the Study Director?

    Answer: The QAU is independent of the Study Director and reports findings to management; the Study Director is responsible for study conduct

    GLP requires the QAU to be organizationally independent of study conduct while the Study Director retains full responsibility for the study.

  4. What continuing education requirement is associated with maintaining the RQAP-GLP credential offered by SQA?

    Answer: Accumulating a required number of professional development units (PDUs) during each recertification cycle

    RQAP-GLP holders must accumulate professional development units (PDUs) to demonstrate ongoing competency for credential renewal.

  5. Which document best prepares a QA inspector for conducting a study-phase audit?

    Answer: The study protocol, relevant SOPs, and any previously issued protocol amendments

    Effective audit preparation requires reviewing the protocol, applicable SOPs, and all amendments to know what requirements apply to the phase being audited.

  6. In the SQA professional community, what does 'mutual recognition' of GLP compliance refer to?

    Answer: An agreement between countries to accept each other's GLP inspections and study data without duplication

    OECD GLP mutual recognition allows signatory countries to accept nonclinical safety studies conducted under GLP in other member countries.

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