Deviation Management Training

Deviation Management Training

✅ Investigate Smarter. Prevent Recurrence. Assure GMP Compliance.

📘 Course Description

This focused training equips pharmaceutical professionals with the tools and knowledge to identify, document, investigate, and close deviations effectively in a GMP-regulated environment. Participants will learn regulatory expectations, root cause analysis techniques, CAPA integration, and risk-based approaches to deviation handling.

The course emphasizes a structured, data-driven approach to deviation management in line with FDA 21 CFR Parts 210/211, EU GMP, and ICH Q10, helping ensure product quality and inspection readiness.

🎯 Learning Objectives

·         Define deviations, categorize them (planned/unplanned, major/minor), and understand their regulatory significance.

·         Apply Good Documentation Practices (GDP) during deviation recording and investigation.

·         Conduct thorough root cause investigations using tools like 5-Whys, Fishbone, and Risk Assessments.

·         Develop effective and sustainable Corrective and Preventive Actions (CAPA).

·         Integrate deviation management with Quality Risk Management (ICH Q9) and QMS elements.

·         Improve response readiness for audits and inspections regarding deviation records.

📚 Course Syllabus

Module 1

Deviation Fundamentals

Module 2

Deviation Reporting & Documentation

·         Definition and Types of Deviations

·         Regulatory Framework: FDA, EU GMP, WHO, ICH Q10

·         Examples of Deviation Scenarios

·         Timely Detection and Notification

·         Deviation Forms and Templates

·         Documentation Best Practices (GDP)

Module 3

Investigation and Root Cause Analysis

Module 4

CAPA & Continuous Improvement

·         Investigation Workflow and Roles

·         Root Cause Tools: 5-Why, Fishbone, FMEA

·         Linking Deviations to Risk Assessments

·         Writing Effective CAPAs

·         Verification of Effectiveness (VoE)

·         Trending, Metrics, and Quality Review

·         Preparing Deviation Files for Audit Readiness

📢 Book Your Seat – Master Deviation Handling and Root Cause Investigations!