Be An Expert In Capa System In 3 Hours!

Manage CAPA's and six sigma quality systems like a pro in your organization.

What you'll learn

Be an expert in CAPA system and work as a CAPA Engineer in Pharmaceutical and med-device industry

Learn about continuous improvement tools such as DMAIC, PDCA Cycle, 8D Methodology

Create Root Cause Analysis (RCA) tools like Ishikawa Chart, Five Whys, Fault Tree Analysis (FTA), Process Maps, Pareto Chart etc..

Create an entire CAPA file from scratch!

Learn different six sigma tools and how it is connected to CAPA system.

Requirements

Basic exposure to medical device/pharma industry.

Description

Corrective and Preventative Action (CAPA) is a system that is widely used in Medical and Pharmaceutical Industry. This course aims to teach you everything there is to know about CAPA system and how to create CAPA file from Scratch. Apart from that you will also learn about various lean six sigma tools such as DMAIC, 8D, PDCA cycle and so on. Whether you are getting ready to appear in an interview or are looking to get a promotion to a CAPA manager from a CAPA Engineer position, this course will help you get there. You will learn in depth of each of the steps to create a successful CAPA. You will also learn how to create various root cause analysis tool such as Fish bone diagram, Pareto Chart, Five whys, process maps, fault tree analysis which will set you apart from rest of your colleagues. You will learn the difference between CAPA and Non conformance and understand when to use one or the other based on the level of risk each failures possess.Buying this course means you will have lifetime access to the material in it so you will be able to revisit any of these section at any time.

Overview

Section 1: Introduction and Overview

Lecture 1 Introduction

Lecture 2 Introduction to CAPA

Lecture 3 Non-conformances VS CAPA - Similarities and difference

Section 2: Deep Dive into CAPA

Lecture 4 Steps under Corrective Action and Preventative Actions

Lecture 5 Regulatory Requirement for CAPA system

Lecture 6 CAPA Process Steps

Section 3: CAPA Step 1: Problem Identification & CAPA Initiation

Lecture 7 Problem Identification Overview

Lecture 8 Problem Description & Statement

Lecture 9 Write Problem Statement and Description from Scratch!

Section 4: CAPA Step 2: CAPA Team and Root Cause Investigation (RCI)

Lecture 10 CAPA Team

Lecture 11 Overview of Root Cause Investigation

Section 5: CAPA Step 3 (a): Quantitative Root Cause Investigation (RCI)

Lecture 12 Quantitative RCI

Lecture 13 When to use which quantitative chart

Lecture 14 Pareto Chart or 80-20 rule.

Section 6: CAPA Step 3. (b): Qualitative Root Cause Investigations

Lecture 15 Overview of Qualitative Root Cause Investigations

Lecture 16 Five Whys (or 5 Whys) Techniques

Lecture 17 Learn how to create Fishbone diagram from Scratch!

Lecture 18 Create Fault Tree Analysis (FTA) from Scratch!

Lecture 19 8D Model (Lean Six Sigma Tools)

Lecture 20 DMAIC (Lean Six Sigma Tool for continuous improvement)

Lecture 21 PDCA Cycle (Lean six sigma tool for continuous improvement)

Lecture 22 Process Maps

Section 7: CAPA Step 4: Risk Assessment & Testing possible solutions

Lecture 23 Risk Assessment

Lecture 24 Narrowing down the root causes

Lecture 25 Root Cause Statement

Section 8: CAPA Step 5: Implementative, Verification and CAPA closure

Lecture 26 Implementation Phase

Lecture 27 Implementation Plan

Lecture 28 Creating Action Item for Solution implementation

Lecture 29 Action Item Completion Verification

Lecture 30 Verification of effective of CAPA

Lecture 31 CAPA Closure

Professional looking to get into Pharma industry or wanting to be promoted to a CAPA Engineer or CAPA manager