A new draft guidance, Learning Strategies to Optimize GxP Training, was submitted to the U.S. Food and Drug Administration (FDA) by industry experts and former officials to encourage a shift toward competency-based, role-specific and measurable training programs.
Join UL Solutions experts as they break down the proposed submitted guidance, discuss its regulatory implications and share practical strategies for strengthening qualification programs, improving training effectiveness and supporting inspection readiness. Learn how organizations are leveraging ULTRUS® ComplianceWire® and training data insights to support workforce qualification and regulatory compliance.
Agenda
New GxP Training Draft Guidance
- Overview of the proposed guidance
- Current status and industry implications
Key Changes Organizations Should Understand
- Moving beyond training completion to demonstrated competency
- Documentation, assessments and role-specific training expectations
What ULTRUS ComplianceWire Data Reveals
- Common training and qualification gaps
- Using training data to strengthen compliance readiness
Building an Implementation Plan
- Evaluating current programs against emerging expectations
- Accelerating qualification and workforce readiness
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