Description: Regulatory requirements found in the CFR that pertain to infant formula (liquid and powder).

Terminal Competency:

Discuss regulatory requirements related to infant formula.

Enabling Competencies:

1. Articulate the requirements found in 21 CFR 107.

2. Summarize the content of 21 CFR 106.

3. Summarize the content of 21 CFR 117.

4. Summarize the content of 21 CFR 108.

5. Summarize the content of 21 CFR 113.

6. Summarize the content of 21 CFR 114.

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: Operations related to the manufacturing of infant formula.

Terminal Competency:

Discuss the infant food manufacturing process.

Enabling Competencies:

1. Define the relevant manufacturing schemes for powdered infant formula production.

2. Define the relevant manufacturing schemes for liquid infant formula production.

3. Describe the purpose/operation of commonly used equipment.

4. Recognize deficiencies associated with manufacturing scheme equipment.

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: Hazards that may be encountered in IF production operations.

Terminal Competency:

Describe hazards that may be encountered in infant formula production.

Enabling Competencies:

1. Articulate hazards in production operations.

2. Describe common sources for hazards.

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: Risk factors in infant formula manufacturing schemes and required preventive controls.

Terminal Competency:

Discuss control measures related to infant formula operations.

Enabling Competencies:

1. Describe the risk factors associated with infant formula manufacturing schemes.

2. Identify applicable preventive controls for wet mix, spray dry, and fill operations.

3. Identify applicable preventive controls for wet mix, spray dry, dry-blend, and fill operations.

4. Identify applicable preventive controls for dry-blend and fill operations.

5. Identify applicable preventive controls for liquid infant formula operations.

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: Sanitation and hygienic controls associated with infant formula operations.

Terminal Competency:

Discuss sanitation and hygienic controls associated with infant formula operations.

Enabling Competencies:

1. Identify applicable sanitation/hygienic controls for wet mix, spray dry, and fill operations.

2. Identify applicable sanitation/hygienic controls for wet mix, spray dry, dry-blend, and fill operations.

3. Identify applicable sanitation/hygienic controls for dry-blend and fill operations.

4. Identify applicable sanitation/hygienic controls for liquid operations.

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: Verification activities associated with infant formula operations.

Terminal Competency:

Discuss verification activities associated with infant formula operations.

Enabling Competencies:

1. Describe discrepancies in powdered infant formula labels.

2. Audit manufacturing records/data for compliance.

3. Recognize when to seek outside assistance.*

4. Analyze environmental monitoring data.

5. Recognize the importance of FDA’s environmental sampling at the firm.

* Applies to all topics in the Infant Formula content area

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: Investigational activities associated with infant formula operations.

Terminal Competency:

Discuss investigational activities associated with infant formula operations.

Enabling Competencies:

1. Evaluate the firm’s root cause investigation.

2. Evaluate the firm’s root cause analysis.

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.