Good Laboratory Practice (GLP) compliance is a critical requirement for nonclinical studies submitted to the FDA. However, many organizations—especially startups, small biotech firms, and emerging laboratories—often perceive GLP as complex, expensive, and resource-intensive. In reality, GLP compliance can be achieved effectively and cost-efficiently with the right understanding, planning, and scalable systems.

This webinar is designed to demystify GLP requirements and show how organizations can meet FDA expectations without unnecessary overhead. The session will focus on practical, real-world approaches to implementing and maintaining GLP-compliant processes while controlling costs and avoiding common compliance pitfalls.

Key Topics Covered in the Webinar

• Understanding Core GLP Requirements
  A simplified explanation of FDA GLP regulations (21 CFR Part 58) and what inspectors truly focus on during audits.
• Right-Sizing GLP Systems
  How to build GLP processes that match your organization’s size, study volume, and risk profile—without overengineering.
• Cost-Effective Documentation Practices
  Creating essential SOPs, study plans, and reports that meet regulatory expectations without excessive paperwork.
• Data Integrity and Record Management
  Practical approaches to ensure ALCOA+ compliance using affordable tools and efficient workflows.
• Vendor and CRO Oversight on a Budget
  Smart strategies for qualifying and managing external labs and CROs without costly audits.
• Inspection Readiness Without Panic
  How to prepare for FDA inspections proactively rather than through last-minute, expensive fixes.

What You Will Learn

• How to interpret FDA GLP expectations in a practical, inspection-ready manner
• Ways to implement GLP-compliant systems without unnecessary costs
• Common GLP mistakes that lead to observations and how to avoid them
• Affordable tools and templates for GLP documentation and data management
• How to maintain compliance while scaling operations

Why Should You Attend?

• Simplify Compliance: Gain clarity on GLP requirements without regulatory jargon.
• Control Costs: Learn how to avoid overspending on systems and consultants.
• Reduce Inspection Risk: Understand what FDA inspectors actually expect to see.
• Build Sustainable Systems: Create GLP processes that grow with your organization.
• Make Informed Decisions: Know when to invest—and when not to.

Who Will Benefit from This Webinar?

• Nonclinical and Preclinical Research Teams
• Quality Assurance and Compliance Professionals
• Regulatory Affairs Professionals
• Biotech and Pharma Startups
• Laboratory Managers and Study Directors
• CRO Oversight and Vendor Management Teams
• Early-stage Companies Preparing for FDA Submissions
• Lab Operations & Data Management Personnel
• CRO Scientists and Lab Leaders
• Start‑ups building GLP systems on tight budgets
• Drug discovery scientists
• Safety pharmacologists and Toxicologists

Join this webinar to learn how GLP compliance can be practical, scalable, and affordable—helping you meet FDA requirements confidently without breaking the bank.