New GxP Training Guidance: What It Means for Compliance

A new draft guidance, Learning Strategies to Optimize GxP Training, was submitted to the U.S. Food and Drug Administration (FDA) by industry experts and former officials to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New GxP Training Draft Guidance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

Learning Objectives

Attendees will learn how to:

• Understand the key elements and implications of the proposed GxP training guidance.
• Identify gaps in training and qualification programs.
• Develop a practical implementation roadmap.
• Use ULTRUS® ComplianceWire® and training data to support compliance and inspection readiness.

Speakers

UL Solutions, Colleen LoConte, Director and GM of Regulatory Lifecycle, ComplianceWire Software

UL Solutions, Patricia Alcock, Senior Training Advisor

UL Solutions, Mark Lee, Senior Training Advisor