Description: Knowledge, skills, and abilities related to the interpretation of regulatory requirements.

Terminal Competency:

Explain the regulatory requirements of a limited scope preventive controls inspection.

Enabling Competencies:

1. Explain 21 CFR 117 Subpart C: Hazard Analysis and Risk-based Preventive Controls.

2. Explain 21 CFR 117 Subpart F: Requirements Applying to Records That Must Be Established and Maintained.

To see a set of behavioral anchors, which provide further detail about the enabling competencies and can be used for assessment against the enabling competencies, contact IFPTI.

Description: Knowledge, skills and abilities to conduct a limited scope preventive controls inspection.

Terminal Competency:

Conduct a limited scope preventive controls inspection.

Enabling Competencies:

1. Identify relevant Subparts.

2. Conduct a broad assessment against 21 CFR 117 Subpart C: Hazard Analysis and Risk-based Preventive Controls.

3. Assess against 21 CFR 117 Subpart F: Requirements Applying to Records That Must Be Established and Maintained.

To see a set of behavioral anchors, which provide further detail about the enabling competencies and can be used for assessment against the enabling competencies, contact IFPTI.