SQA SQA Inspector Roles and Responsibilities

Question 1

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

Accepted Answer

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

Answer

To enforce GLP regulations on behalf of the FDA

Answer

To certify GLP laboratories as FDA-compliant

Answer

To conduct third-party GLP audits for regulatory agencies

Question 2

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

Accepted Answer

Registered Quality Assurance Professional (RQAP-GLP)

Answer

Certified Quality Auditor in GLP (CQAGLP) through SQA's certification program

Answer

Certified GLP Compliance Officer (CGCO)

Answer

Licensed Quality Inspector (LQI)

Question 3

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

Accepted Answer

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

Answer

Only the date and inspector name

Answer

Study director approval and sponsor name only

Answer

Findings only, without dates or personnel information

Question 4

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

Accepted Answer

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

Answer

The QAU may conduct studies provided they report findings objectively

Answer

Conflicts of interest are allowed if disclosed in the QAU statement

Answer

The Study Director and QAU may be the same person for small facilities

Question 5

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

Accepted Answer

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

Answer

Halt the study immediately without notification

Answer

Submit a report directly to the FDA

Answer

Document the finding and wait until the final report to disclose it

Question 6

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

Accepted Answer

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

Answer

Focusing only on findings that affect study conclusions

Answer

Adjusting findings based on the study's regulatory importance

Answer

Omitting minor findings to maintain a positive relationship with study personnel