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With the expertise of FDA officials and seasoned professionals, the 18th Annual FDA Inspections virtual Summit will tackle complex inspection issues head-on — providing details that will ease the stress of your next agency visit, including:

ORA Reorganization Plans

Learn how the Office of Regulatory Affairs plans to better support its public health mission.

Understanding Remote Inspection Procedures

Ensure your facility is prepared for remote FDA evaluation.

Managing Data and Documentation

Learn tips and tricks to create effective new SOPs for electronic document management or improve your existing ones.

Mock Investigator Interview

Learn the tactics FDA trains its investigators to use to get all the information they need — and sometimes more than you want them to have — from interviews with your staff.

Choose from two tracks — Drugs & Biologics or Medical Devices — to guarantee your inspection readiness and comfort with the tools and tactics you’ll need to apply when you are face to face with an FDA investigator:

Drug & Biologics industry leaders will discuss what you must know about CAPA, provide an investigator’s view of a drug or biologics inspection, and discuss how to implement a risk management program that will pass inspection.

Medical Device experts will dive into the new Quality Management System Regulation, challenges of using artificial intelligence in medical devices, and new strategies for streamlining CAPA.

There’s no other summit where you’ll leave as well informed for the complicated task of preparing for an inspection. Don’t miss this opportunity to learn from FDA and other inspections experts to ensure your team is prepared for compliance and a successful inspection.