Go beyond procedural compliance — learn how FDA and MHRA investigators evaluate laboratory oversight maturity and build defensible data integrity practices that hold up under real inspection scrutiny.
Includes live access & recording
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.
This practical 90-minute webinar examines modern GMP laboratory data integrity expectations through the lens of current FDA and MHRA inspection thinking, using real-world observations, operational scenarios, and practical examples throughout.
Many GMP laboratories already have data integrity procedures, audit trail reviews, training programs, and electronic systems in place. Yet inspection findings 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.
This webinar provides a practical, investigator-minded perspective on how GMP laboratories can strengthen data integrity maturity beyond procedural compliance alone — building controls that genuinely improve inspection readiness.
Four investigator-minded focus areas that will elevate your laboratory's data integrity maturity and inspection readiness.
Understand how FDA and MHRA investigators interpret laboratory risk signals, evaluate oversight maturity, and determine whether data integrity issues represent isolated events or systemic concerns.
Learn to distinguish between controls that merely appear compliant and controls that genuinely reduce inspection vulnerability — a critical difference that modern regulators are trained to identify.
Identify common operational practices that create data integrity exposure — including spreadsheet vulnerabilities, hybrid workflow gaps, access control weaknesses, and ineffective review activities.
Build more defensible audit trail review strategies, QA escalation frameworks, and risk prioritization approaches that demonstrate meaningful operational control to inspectors.
Eight focused topics covering the full scope of GMP laboratory data integrity in today's FDA and MHRA inspection environment.
Quality, compliance, and laboratory professionals in pharmaceutical, biotech, and medical device organizations responsible for GMP data integrity and inspection readiness.
Quality Assurance (QA)
Quality Control (QC)
Analytical Development Laboratories
Regulatory Affairs
Compliance and Validation Teams
Manufacturing and Operations
Laboratory Managers and Supervisors
CMC and Technical Services Professionals
Data integrity in GMP laboratories has been a sustained enforcement priority for both the FDA and MHRA for over a decade, but the nature of inspection scrutiny continues to evolve. Early enforcement activity focused primarily on obvious documentation falsification and missing records. Today, regulators have developed a far more sophisticated approach — one that examines the behavioral, systemic, and governance dimensions of data integrity rather than just the presence or absence of individual records.
Organizations often struggle to distinguish between controls that merely appear compliant and controls that truly reduce inspection vulnerability and operational risk. A laboratory can have comprehensive SOPs, completed training records, and functioning electronic systems while still exhibiting the underlying patterns of behavior, oversight gaps, and risk acceptance that trigger escalated regulatory concern. Modern investigators are specifically trained to identify this disconnect.
The FDA's Data Integrity and Compliance guidance, the MHRA GXP Data Integrity Definitions and Guidance, and ongoing enforcement trends from both agencies make clear that laboratories are expected to demonstrate genuine operational control — not just documentation of procedures. This session equips participants with the investigator's perspective needed to evaluate their own laboratory's data integrity posture honestly, identify real vulnerabilities, and build sustainable improvements that reduce inspection risk in 2026 and beyond.
Meredith Crabtree has over 30 years of experience in regulated industries spanning Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health — including manufacturing, packaging, labelling, and distribution operations.
Meredith is the owner of MLKC Consulting, a quality consulting firm specializing in product label reviews, third-party inspections, Consent Decree and Recall support. She also performs regulatory assessments and quality training across a wide range of regulated sectors.
Her extensive cross-industry experience and hands-on inspection support background give her a uniquely practical perspective on what regulators observe during GMP inspections — and what organizations must do to build quality systems and data integrity practices that stand up under real-world scrutiny.
Join Meredith Crabtree for this 90-minute deep-dive into modern GMP data integrity expectations — and build the inspection readiness your laboratory needs in 2026.