Minnesota Chapter: Knock, Knock! Who's there and are you prepared?

When:  Oct 26, 2019 from 08:00 AM to 02:30 PM (CT)
Associated with  ACRP Upper Midwest Chapter

Knock, Knock! Who's there and are you prepared?

Please Click Here to Purchase your Contact Hours

Target Audience:
  • CRCs
  • CRAs
  • Auditors
  • Project Managers
  • Regulatory Affairs/Compliance
  • Data Managers (Site, Sponsor, CRO)
  • Quality Assurance
  • Clinical Research Administrators

Program Description:
You never know who could be knocking. As clinical researchers we tend to live in fear that it is the FDA. But this is not the way to live our professional lives. So, the MN Chapter has decided to provide you with direct from the source information about what to expect is the FDA does come knocking. Then we will provide you some awesome examples of what other did (and you shouldn’t), followed by how to really get your organization prepared. It should be a great day of learning and interactive conversations.

Program Agenda:

  • 8:00-8:30 a.m. Registration and Light Breakfast
  • 8:30-8:45 a.m. Welcome Address
  • 8:45-10:15 a.m. Knock, knock . . .FDA is here; Be prepared for a Regulatory Inspection
  • 10:15-10:30 a.m. Break
  • 10:30 a.m.-12:00 p.m. They did WHAT?! Learning from misadventures in the field
  • 12:00-12:45 p.m. Lunch Case Study: What would to with a problem site knowing that the FDA will be knocking?
  • 12:45-1:15 p.m. Case Study Review
  • 1:15-2:15 p.m. Always Audit Ready: The Busy Clinical Researcher’s Guide to Audit Preparation and CAPA Plans
  • 2:15-2:30 p.m. Closing Remarks
  • Eric Pittman, US FDA
  • Dr. Sandy Shire, Former FDA Inspector and Professor of the Clinical Research Management at ASU
  • Lisa Haney, Director of Research, nura Precision Pain Management
Learning Objectives: 
  1. Understand what the FDA is looking for when they conduct an inspection
  2. Gain insight into what can happen if there are findings at an FDA inspection
  3. Prepare effectively for an FDA audit

Registration Fees:
  • Chapter Members: $60
  • ACRP Members: $90
  • Non-Members: $100
Contact Hour Fees:
  • Chapter Members: $0
  • ACRP Members: $25
  • Non-Members: $40

* Please Note: If you are looking to recieve Contact Hours for this event, you will have to pay both the Registration Fee and Contact Hour Fee.

Contact Hours:
 Five Contact Hours

Refund/Cancellation: No refunds.


Walker Art Center—Skyline Room
725 Vineland Place
Minneapolis, MN 55403