[Bonus Issue] Inside FDA's Pre-Approval Inspections with Former FDA Investigator, Christopher Smith

Former FDA Investigator, Christopher Smith shares his insights on FDA Pre-Approval Inspections (PAIs).

Mar 16, 2023

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In October 2020, The FDA Group’s CEO, Nick Capman, sat down with former FDA Investigator and current consultant Chris Smith to discuss how FDA plans and conducts its PAIs—and how industry teams can effectively prepare for them.

Chris has more than 35 years of experience, having held senior positions at FDA, large and small pharmaceutical companies, and contract research organizations. 

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Here are the main points Chris reveals in this conversation:

An effective PAI preparation process involves:

  • Setting up a team responsible for inspection readiness

  • Physical preparation for the inspection

  • Conducting a mock PAI.

  • The mock PAI should be done at least a year ahead of the FDA inspection, with a thorough report produced to communicate the findings of the mock inspection.

  • Remediation activities should then be prioritized according to risk, using the necessary mechanisms, such as CAPA, to carry them out.

  • The FDA Compliance Program Guides and other regulations and guidance documents can be useful resources during the preparation process.

  • Companies should also focus on conducting and writing excellent investigations.

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Learn more about our mock PAI services here or contact us and get the conversation started. Download our case study below to see how we helped a large healthcare product company support their PAI preparation project and subsequent quality system remediation efforts on time and 15% under budget.

📄 Free case study: International PAI Audit Preparation & Remediation Project

Learn how The FDA Group partnered with a large healthcare product Company to support a Pre-Approval Inspection (PAI) audit preparation project and subsequent quality system remediation efforts at a site within the European Union (EU)—completing the project on time and 15% under budget.

Read the case study

Read our PAI prep guide

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