The US Food and Drug Administration (FDA) is responsible for regulating the safety, efficacy, and quality of therapeutic products that save or improve human lives. Firms looking to approve pharmaceuticals, biopharmaceuticals, and medical devices must comply with these regulations or face sanctions and/or setbacks.
A significant part of the FDA pre-approval process remains inspection actions by the agency to ensure quality, consistency, and safety. Readiness for these inspections is paramount. Having bullet-proof data, documentation, standard operating procedures (SOPs) and other items in place is just part of the puzzle. The people who handle these inspections and all interactions with FDA must be thoroughly screened and selected as well. Since this is likely your “first impression” with FDA, you have no choice but to get it right.
FDA pre-approval inspections will focus on the past (corroboration of the data on which approval will be based), present (your organizational structure, delegation of responsibilities, written procedures, quality systems, culture of compliance) and future (your understanding and readiness for post-approval statutory obligations, including commercial vigilance plans).
This 90-minute session will provide you with an understanding of:
- Why you will be inspected
- Why you should plan for inspections
- How to best prepare for such inspections
- Best practices for hosting, supporting and engaging in FDA inspections
- What you must provide versus what you should not provide
- How to respond to and process inspectional observations documented in Form FDA 483, including remediation during the inspection
- How to communicate with the inspectorate: What to say and what not to say
Upon completion of the course, you will have a full and balanced understanding of the inspectional process and how to effectively prepare and participate using a strategy designed for a favorable outcome while minimizing risks. Additionally, an “Inspection Readiness Checklist” will be provided to participants as a useful job-aid.