Regulatory Inspections - How to prepare for a visit from an FDA Auditor

This FDA audit webinar will highlight the purpose of FDA audits and scope, Understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before and after the audit.

Why Should You Attend:

This presentation will cover how to best prepare for these inspections to ensure the process is as quick and seamless as possible. We will cover what they are required to ask for, what they will likely ask for, and how to ensure you provide information requested in a timely manner. We will also go over some tips and tricks that will also help in ensuring a smooth audit as well as how to respond to the FDA once the audit is complete. At the end of the presentation, I will answer any questions or concerns you may have regarding the FDA auditing process.