Deviation Handling and GMP Investigations

Level

Introductory

Format

On-site, practical, including essential theory

Duration

Half-day

Cost

$543

Overview

When deviations arise, the strength of your investigation process directly influences product safety, regulatory compliance, and your organization’s credibility. This course provides participants with the mindset, methodologies, and practical tools needed to handle GMP deviations as regulators expect—using a structured, compliant approach that prioritizes accurate root cause identification.

Through a realistic, scenario-based approach, participants are immersed in a simulated deviation case, working collaboratively to analyze root causes and apply tools such as the 5 Whys and Ishikawa (Fishbone) diagrams. The training fosters critical thinking, cross-functional collaboration, and practical application of GMP principles.

Why It’s Essential

Poorly executed investigations are a leading cause of regulatory findings and can derail production timelines, trigger compliance observations, and erode trust with regulators and partners. This course enables participants to:

• Prevent regulatory observations: Produce clear, complete, and defensible investigation reports that withstand audit scrutiny
• Strengthen root cause analysis: Use proven tools and sound judgment to identify and address true underlying causes, preventing recurrence rather than treating symptoms
• Increase competency: Build a shared understanding of investigation best practices to improve efficiency, shorten investigation timelines, and avoid costly rework
• Foster a quality-first culture: Promote cross-functional problem solving and ownership of deviations across all levels of the organization

This course builds the mindset your team needs to resolve deviations efficiently and effectively.

Learning Objectives

• Understand the role and impact of investigations in a GMP/GxP environment

• Navigate the investigation lifecycle: detection, containment, analysis, action, and closure

• Apply proven root cause analysis tools (5 Whys, Ishikawa/Fishbone diagram) to find and fix issues at their source

• Understand the requirements to properly document investigations and identify corrective and preventive actions (CAPAs)

• Practice problem-solving through real-world GMP scenarios and group discussion

Who Should Attend

This course is designed for organizations operating under GMP that are committed to elevating deviation management, strengthening investigation quality, and enhancing audit readiness. It is recommended for:

• New industry hires onboarding into GMP roles 
• Quality assurance (QA) professionals who lead or support deviation resolution 
• Production operators, supervisors, or subject matter experts (SMEs) who initiate or participate in investigations 
• Maintenance and qualification engineers involved in root cause analysis 
• Quality control (QC) personnel supporting investigations

Participants who successfully complete a theoretical assessment will receive a certificate of completion.