Faculty: Meredith Crabtree | Code: FDB1416
GMP laboratory data integrity failures continue to remain a major inspection focus for FDA and MHRA investigators, particularly as laboratories become more digitally complex and increasingly dependent on hybrid workflows, computerized systems, audit trails, spreadsheets, and interconnected data environments. While most organizations have implemented standard procedural controls and ALCOA+ training, regulators continue to identify deeper operational weaknesses involving oversight effectiveness, analyst practices, access management, data review quality, and decision-making within laboratory operations.
In many cases, inspection concerns do not originate from a single missing record or isolated documentation issue. Instead, investigators assess whether laboratory behaviors, review practices, governance structures, and quality oversight collectively demonstrate reliable control over data generation, review, reporting, and escalation activities. Organizations often struggle to distinguish between controls that merely appear compliant and controls that truly reduce inspection vulnerability and operational risk.
This practical 90-minute webinar examines modern GMP laboratory data integrity expectations through the lens of current FDA and MHRA inspection thinking. The session will explore how investigators interpret laboratory practices, identify hidden risk signals, evaluate oversight maturity, and determine whether data integrity weaknesses represent isolated events or broader systemic concerns.
Real-world inspection observations, operational scenarios, and practical examples will be used throughout the session to help participants strengthen inspection readiness, improve risk prioritization, and build more defensible laboratory oversight and data integrity practices.
Many GMP laboratories already have data integrity procedures, audit trail reviews, training programs, and electronic systems in place. However, inspection findings related to laboratory oversight, analyst practices, access management, documentation reliability, and ineffective review activities continue to rise because regulators increasingly evaluate how organizations apply judgment, prioritize risk, and maintain meaningful operational control under real-world conditions.
Modern inspections are becoming more targeted, risk-focused, and signal-driven. Investigators are no longer assessing only whether procedures exist, but whether laboratory practices consistently demonstrate reliable execution, effective oversight, and credible decision-making across daily operations. In many organizations, hidden vulnerabilities develop gradually through routine practices that teams no longer recognize as inspection risks.
This webinar provides a practical and investigator-minded perspective on how GMP laboratories can strengthen data integrity maturity beyond procedural compliance alone. Participants will learn how inspectors interpret laboratory behaviors, identify patterns that trigger deeper scrutiny, and distinguish between low-value compliance activity and controls that genuinely improve inspection readiness.
The session will also help attendees develop more practical strategies for risk prioritization, oversight effectiveness, operational consistency, and sustainable data integrity governance within modern GMP laboratory environments.
Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.