Preparing for an FDA Pre-Approval Inspection (PAI) – “Begin with the End in Mind.”

"Begin with the End in Mind"

Explore the significance of this principle in FDA Pre-Approval Inspection preparation. Focus on aligning the production process with NDA/BLA requirements.

When to Begin Preparation?

Commence preparation during product development, ensuring documentation for the CMC Section supports a robust Pre-Approval Inspection.

Understanding FDA's Objectives

Discover the three key objectives of an FDA Pre-Approval Inspection: adherence to NDA/BLA info, facility readiness, and data integrity.

Common Pitfalls in Inspection

Identify areas where firms struggle, from documentation storage to formula changes. Address these issues for a smooth Pre-Approval Inspection.

Key to a Favorable Outcome

Introduce a CMC Maturity Model to self-assess readiness. Ensure your organization is well-prepared for a successful Pre-Approval Inspection.

Preparing for an FDA Pre-Approval Inspection (PAI) – “Begin with the End in Mind.”