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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.
This conversation was originally published as an episode of our companion podcast, The Life Science Rundown.
We also expanded this interview into a comprehensive written guide on our blog: Pre-Approval Inspection (PAI): An Expert Guide to Preparation.
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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.
Schedule a Mock PAI with The FDA Group.
We've helped many life science companies plan and execute mock PAIs and support subsequent remediation projects. Our large staff of industry experts and former FDA investigators minimize internal disruption and help ensure full confidence in your state of preparedness.
From regulatory observation responses to inspection readiness, our large staff of compliance specialists can tackle virtually any challenge and move your organization forward in a continuous and complete state of regulatory compliance.
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.
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Need expert help planning and executing compliance projects or connecting with a quality and compliance professional? Get in touch with us. If we haven’t worked together yet, watch our explainer video below or head to our company introduction page to see if we could help you execute your projects now or in the future—all in less than 4 minutes.
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