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

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

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

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

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

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

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

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

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

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA SQA Inspector Roles and Responsibilities 2