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GMP Laboratory Data Integrity in 2026: Practical Strategies for FDA and MHRA Inspection Readiness

** Registration to this course includes Trial access to TalkFDA Subscription and Members-only Community. Contact our Support for more details after the course completion.

This course helps laboratory and quality teams strengthen data integrity oversight, prioritize real inspection risks, and improve review practices across computerized, hybrid, spreadsheet-based, and audit trail environments. This Course is designed for professionals responsible for laboratory operations, quality oversight, analytical review activities, computerized systems, or GMP data governance practices.

  • 12 June 2026
  • Eastern Time (US/Canada): 11.00 AM
  • GMT: 3.00 PM
  • 60 Minutes
  • FDB1416
  • Meredith Crabtree
  • Live Session + Post-live Continued Learning
  • Live Q&A Included
  • Presentation Handout & Templates
  • Assessment & Certification Included

REGISTRATION OPTIONS

Live session Plus Complimentary 30 Days Streaming access

$190  |  One participant (viewer)

$290  |  Team of up to 5 participants

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Why take this course?

GMP laboratory data integrity remains a major inspection focus for FDA and MHRA investigators as laboratories rely more heavily on computerized systems, audit trails, spreadsheets, hybrid workflows, and interconnected data environments. Standard procedures and ALCOA+ training may be in place, yet inspection concerns continue to arise around analyst practices, access management, review quality, oversight effectiveness, and escalation decisions. These issues often signal broader weaknesses in how laboratory data is generated, reviewed, reported, and controlled.

This program focuses on practical inspection readiness for modern GMP laboratories. It examines how investigators interpret laboratory behaviors, identify hidden risk signals, and assess whether oversight practices demonstrate meaningful operational control rather than procedural compliance alone. Attention is given to audit trail review value, spreadsheet and hybrid workflow vulnerabilities, QA oversight, risk prioritization, and sustainable laboratory governance.

  • Recognize hidden laboratory data integrity risks:

    Inspection concerns often come from routine behaviors that appear acceptable internally but signal weak control to investigators. This course helps teams identify exposure linked to analyst practices, access management, hybrid workflows, spreadsheets, audit trails, and escalation decisions before those patterns become inspection findings.

  • Strengthen oversight beyond procedural compliance:

    Having procedures does not prove laboratory data is under control. This course improves how QA, QC, and laboratory leaders evaluate review effectiveness, risk prioritization, and governance maturity. The result is stronger readiness for FDA and MHRA inspections that assess execution, judgment, and operational consistency.

Key Areas Covered

  • Current FDA and MHRA expectations for GMP laboratory data integrity
  • How investigators interpret laboratory risk signals and oversight maturity
  • Operational practices that create hidden data integrity exposure
  • Distinguishing procedural compliance from meaningful operational control
  • Audit trail review strategies that provide real inspection value
  • Spreadsheet, hybrid workflow, and access control vulnerabilities
  • QA oversight, escalation decisions, and risk prioritization
  • Practical approaches for improving laboratory governance and inspection readiness

Who Must Attend

  • Quality Assurance (QA) Departments
  • Quality Control (QC) Departments
  • Analytical Development Laboratories
  • Regulatory Affairs Departments
  • Compliance and Validation Teams
  • Manufacturing and Operations
  • Laboratory Managers and Supervisors
  • CMC and Technical Services Professionals
COURSE DIRECTOR

Meredith Crabtree

Meredith Crabtree has over 30 years of experience across regulated industries including laboratory, pharmaceutical, medical device, manufacturing, packaging, labeling, and distribution operations. Her work in regulatory assessments, third-party inspections, consent decree support, recall support, and quality training aligns directly with laboratory oversight, inspection readiness, and practical data integrity governance.

If you would like to request a Proforma invoice to sign up for this course. please click here

Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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Testimonials

This is an upcoming session. Feedback below reflects experiences from similar programs delivered by our expert faculty.

“Session was easy to follow even for non-core team members. That helped.”
- Production Officer
“Good balance. Not too basic, not too deep. Worked well for mixed team.”
- Manager, Regulatory Affairs
“Team found it useful. Especially for aligning understanding across functions.”
- Director, Operations

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