Name
C190b - Good Clinical Practice and Inspection Readiness (Part 2)
Date & Time
Sunday, May 1, 2022, 2:45 PM - 5:45 PM
Description

In this session, we will examine real-world examples of common inspection findings and the importance of proactive quality assurance, continuous quality improvement, study conduct according to GCP, and the development of appropriate CAPA’s so you can avoid and mitigate inspection findings.

Learning Objectives
  1. Describe GCP inspection approaches in the United States and globally.
  2. Explain how to be ready for audits and inspections in clinical trials
Speakers
Linda Coleman - Director, Human Research Protection Program - Yale University (Speaker, Leader)
Janet Holwell - Clinical Research Consultant/Trainer - Holwell Clinical Research Consulting (Speaker)
Patricia Mendoza - Senior Quality Assurance Auditor - Medpace (Speaker)
Laura Odwazny - Senior Attorney - US Department of Health and Human Services (Speaker)
Linda Coleman Janet Holwell Patricia Mendoza Laura Odwazny
Track
C - Regulatory Compliance
Location Name
Back Bay C