Use the scheduling tool below to browse all the available sessions, speakers and topics at this year's event. Find the content and sessions to fit all of your educational needs and ensure you get the most out of your time at the show.

How’s Your Relationship? Working with FDA for Successful Product Launch


Mary Hole (Supervisory Investigator, FDA)

Location: 210D

Date: Thursday, February 8

Time: 2:30pm - 3:45pm

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

You can successfully meet any FDA inspection’s expectations with appropriate planning, timely communication, and transparency. Through manufacturing inspections mandated by Congress, FDA safeguards consumers’ safety and efficacy of the products it regulates protecting US population including those products consumed by you and your family. This session will help you understand how to be prepared and know what to expect when the agency comes knocking at your manufacturing site.

Topics to be covered include:

  • How the Agency operates and its new Program Alignment structure in the field
  • FDA regulatory authority to conduct inspections of manufacturing sites
  • What to expect during an inspection
  • Getting ready for your inspection
  • What are 483s and how to address them
  • How to collaborate with FDA to ensure compliance with FDA Law