US FDA Inspection and SMEs Role

Before Inspection

1. Review relevant regulations and guidelines.
2. Familiarize themselves with inspection procedures.
3. Prepare documentation and data.

During Inspection

1. Be transparent, open, and honest.
2. Provide clear, concise answers.
3. Clarify any misunderstandings.
4. Admit when unsure or lack information.
5. Offer additional information relevant to the question.

Key Phrases

1. “That’s a great question, let me clarify…”
2. “I’m not sure, but I can find out…”
3. “Yes/No, and here’s why…”
4. “We follow [SOP/Procedure] for that.”
5. “I can provide documentation on that.”

Best Practices

1. Listen attentively.
2. Take notes.
3. Ask for clarification.
4. Stay calm and professional.
5. Avoid defensiveness.

Common FDA Inspection Questions

1. What is your role/responsibility?
2. Can you explain [process/procedure]?
3. How do you handle [specific scenario]?
4. What training have you received?
5. Can you provide documentation?

After Inspection

1. Document discussion and findings.
2. Address any observations or issues.
3. Implement corrective actions.

Additional Tips

1. Know your data and systems.
2. Be prepared to demonstrate procedures.
3. Show willingness to improve.
4. Communicate with your team.
5. Follow up on any commitments.

By following these guidelines, SMEs can effectively communicate with US FDA inspectors.

Read also:

• FDA Inspection Readiness Checklist
• Pre-FDA Audit Inspection Day Checklist
• Internal Audit Process in the Pharma Industry

Resource Person: Rajesh Jain