SQA SQA Inspector Roles and Responsibilities 2

Question 1

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

Accepted Answer

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

Answer

Expertise in the scientific methodology of the study

Answer

Ability to recalculate all statistical analyses

Answer

Proficiency in the laboratory's instrument software

Question 2

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

Accepted Answer

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

Answer

To certify new GLP facilities for FDA approval

Answer

To issue annual GLP compliance reports to regulatory agencies

Answer

To train FDA inspectors on GLP audit techniques

Question 3

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

Accepted Answer

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

Answer

The QAU reports to the Study Director and follows their direction on what to inspect

Answer

The Study Director and QAU jointly sign the final report as co-equal authors

Answer

The QAU supervises the Study Director's activities throughout the study

Question 4

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

Accepted Answer

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

Answer

Passing an annual written examination

Answer

Publishing at least one peer-reviewed article per year

Answer

Completing a supervised audit at an FDA-inspected facility annually

Question 5

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

Accepted Answer

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

Answer

The facility's master schedule only

Answer

The previous year's FDA inspection report

Answer

The sponsor's audit history from prior studies

Question 6

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

Accepted Answer

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

Answer

A reciprocal audit arrangement between two test facilities

Answer

FDA and EPA jointly accepting the same study for submission

Answer

Sponsors and test facilities jointly certifying study compliance