Inspection Essentials 2021 - FDA Inspection Essentials in 2021

Upon completion of this session, you will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the audit.
You need not dread an FDA inspection if you are adequately prepared. FDA inspections have revealed some trends in recent years. The agency is taking a tougher stand on Quality Systems and using a risk-based approach. Inspectors usually review at least two (2) systems in depth.
Unannounced FDA visits – how to prepare and react
Preparing for FDA audits / PAI preparation – what training should look like for key players
Basic concepts that should be employed by everyone regulated by the FDA – review of quarterly quality topics to keep current
Speaker:
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order