Capa In Practice: From Investigation To Effective Actions

Master CAPA with real case studies, templates, and root cause analysis tools

What you'll learn

Understand the CAPA lifecycle in the pharmaceutical industry — from deviation to closure.

Apply Root Cause Analysis (RCA) methods such as 5 Why’s, Ishikawa (Fishbone), Fault Tree Analysis, and Human Error templates.

Write clear and effective CAPA records using SMART criteria and regulatory expectations (FDA, EMA, ICH Q10, ISO 9001).

Perform effectiveness checks and prepare CAPA documentation ready for audits and inspections.

Use practical templates, checklists, and case studies to create professional CAPA reports that prevent recurrence of issues.

Requirements

No specific background is required, but a basic understanding of GMP or Quality Assurance in pharma/biotech is helpful.

Students working in production, QC, QA, or regulatory affairs will benefit most.

All necessary templates, examples, and explanations will be provided during the course.

Description

Do you struggle with recurring deviations, “human error” investigations, or CAPAs that inspectors don’t accept?This course gives you practical, step-by-step guidance to build CAPA records that are clear, compliant, and effective.Through real pharma case studies and downloadable templates, you will learn how to:Investigate quality events and find the true root cause (not just “human error”)Write SMART actions that auditors will acceptProve effectiveness with data, trending, and KPIsAvoid common CAPA mistakes that lead to FDA 483s and Warning LettersBy the end of this course, you’ll be confident in handling CAPA investigations from start to closure—turning a painful process into a real improvement tool.What you’ll learn (short bullets for Udemy search)CAPA requirements (FDA, EMA, ICH Q10, ISO 9001)Difference between CAPA, deviation, OOSCAPA lifecycle: initiation → investigation → action → effectiveness → closureRoot Cause Analysis tools: 5 Whys, Ishikawa, Fault TreeHow to write effective Corrective & Preventive ActionsCAPA effectiveness checks (audits, trends, KPIs)Common inspection findings & how to avoid themReady-to-use CAPA forms & filled examplesWho this course is forQA/QC staff in pharma & biotechLab analysts & production operators involved in deviationsCompliance & regulatory professionals preparing for inspectionsStudents or junior professionals who want to upgrade their CAPA skillsRequirementsNo prior CAPA experience requiredBasic pharma/biotech process knowledge is helpful

Overview

Section 1: Introduction to CAPA

Lecture 1 What is CAPA (Corrective and Preventive Action)

Lecture 2 Why CAPA is needed: regulatory requirements (FDA, EMA, ICH Q10, ISO 9001)

Lecture 3 CAPA vs Deviation vs OOS — differences and interconnections

Lecture 4 Examples of CAPA failures during inspections (case studies)

Section 2: CAPA Lifecycle (From Deviation to Closure)

Lecture 5 CAPA lifecycle: identification → investigation → action plan → implementation →

Lecture 6 Roles and responsibilities (QA, production, laboratory, management)

Lecture 7 Time management and prioritization (critical vs minor CAPA)

Section 3: Root Cause Analysis (RCA) — Finding the True Cause

Lecture 8 Why “Human Error” is not a sufficient RCA

Lecture 9 Methods of root cause analysis: 5 Why’s Fishbone (Ishikawa) Human Error

Section 4: Developing CAPA

Lecture 10 How to define Corrective Actions (immediate measures)

Lecture 11 How to define Preventive Actions (eliminating the cause)

Lecture 12 SMART CAPA criteria (Specific, Measurable, Achievable, Relevant, Time-bound)

Lecture 13 Examples of well-written and poorly written CAPAs

Section 5: CAPA Effectiveness Check

Lecture 14 What is an Effectiveness Check

Lecture 15 Methods of verification (trend analysis, audits, retesting, KPIs)

Lecture 16 Examples of “failed CAPAs” and how to fix them

Section 6: CAPA and Inspections (FDA / EMA)

Lecture 17 Typical inspector questions about CAPA

Lecture 18 How to prepare for a CAPA-related audit

Lecture 19 Tips for answering difficult inspector questions

QA specialists and QC analysts in pharmaceutical or biotech companies.,Production and laboratory staff who need to understand CAPA processes.,Regulatory affairs and compliance professionals preparing for inspections.,Beginners in Quality Assurance who want practical tools and templates to start working with CAPA.,Anyone preparing for audits (FDA, EMA, ISO 9001) and looking to strengthen their CAPA knowledge.