Ms. Holwell is a trusted clinical research consultant and trainer with nearly 50 years of experience across clinical sites and the broader research industry. She helps clinical research professionals build expertise and confidence through practical training, quality support, and guidance tailored to today’s regulatory expectations. Her expertise includes Good Clinical Practice (GCP) instruction and training for clinical research professionals, quality support across the clinical research process for domestic and international clients, practical guidance in ICH-GCP compliance, and inspection-readiness support and solutions.

Session:

• What Happens After FDA Inspections: How to Respond with Confidence