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

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"Begin with the End in Mind"

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When to Begin Preparation?

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Understanding FDA's Objectives

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Common Pitfalls in Inspection

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Key to a Favorable Outcome

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

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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.”