Western Michigan

SOCRA West Michigan Chapter

When: Wednesday, December 4th, 2024 at noon (EST)

Where: Join Zoom Meeting
https://us05web.zoom.us/j/82570492480?pwd=mKrSMnbyb4OaXw3HvQmJ549b9of7ri.1

Meeting ID: 825 7049 2480
Passcode: 2IMcKp

Topic:  Inspection Preparedness

Learning objectives:

  • Understand FDA regulations and Good Clinical Practice (GCP) requirements for clinical research, focusing on protocol adherence, records management, and patient rights.
  • Learn about the FDA's Bioresearch Monitoring Program and the Clinical Investigator inspection process.
  • Gain insight into FDA GCP inspection strategies, common findings, and how to prepare for an inspection.

Speaker:  Jeannie Farnsworth, MS, BS, CCRP, MRQA

About the Speaker:

Jeannie Farnsworth is an experienced clinical research professional with over 24 years of expertise across industry-sponsored, investigator-initiated, and cooperative group trials. She has a strong background in large, global clinical trials, multicultural team collaboration, site operations and management, leveraging technology, upholding patient safety and treatment efficacy, and ensuring clean, credible data with scientific merit. She is currently in the role of Clinical Scientist with the title of Associate Director, Clinical Pharmacology. 

 

Please RSVP prior to the meeting of your interest in attending to:  dmarkus@arcpc.net 

 

SoCRA has approved (1) CE credit for this meeting for SoCRA members.  Only SoCRA members will receive a certificate of attendance after the presentation.  Members and non-members welcome.

Chapter Chairperson:

Debra Markus, CCRP
Email