#458: Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations
Monday, June 15, 2026 4:00 PM to 5:00 PM · 1 hr. (America/New_York)
117
02: ClinicalTrialOps-Innovation09: RD-Quality-Compliance
Information
Explore global GCP inspection outcomes featuring FDA’s 7-year data and international trends, highlighting compliance patterns, regulatory harmonization, and industry strategies for sustaining quality in complex global trials
CE
ACPECMERN
Session Level
Intermediate
Learning Objectives
Examine GCP inspection classification and outcomes across regulatory agencies, highlighting similarities and differences in enforcement; Identify common deficiency patterns and regulatory expectations across regions, emphasizing protocol adherence, recordkeeping, and data integrity; Recognize the impact of inspection observations on regulatory decisions; Discuss industry best practices.
