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


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