Manage CAPA’s and six sigma quality systems like a pro in your organization.
What you will 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.
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.
English
language
Content
Introduction and Overview
Introduction
Introduction to CAPA
Non-conformances VS CAPA – Similarities and difference
Deep Dive into CAPA
Steps under Corrective Action and Preventative Actions
Regulatory Requirement for CAPA system
CAPA Process Steps
CAPA Step 1: Problem Identification & CAPA Initiation
Problem Identification Overview
Problem Description & Statement
Write Problem Statement and Description from Scratch!
CAPA Step 2: CAPA Team and Root Cause Investigation (RCI)
CAPA Team
Overview of Root Cause Investigation
CAPA Step 3 (a): Quantitative Root Cause Investigation (RCI)
Quantitative RCI
When to use which quantitative chart
Pareto Chart or 80-20 rule.
CAPA Step 3. (b): Qualitative Root Cause Investigations
Overview of Qualitative Root Cause Investigations
Five Whys (or 5 Whys) Techniques
Learn how to create Fishbone diagram from Scratch!
Create Fault Tree Analysis (FTA) from Scratch!
8D Model (Lean Six Sigma Tools)
DMAIC (Lean Six Sigma Tool for continuous improvement)
PDCA Cycle (Lean six sigma tool for continuous improvement)
Process Maps
CAPA Step 4: Risk Assessment & Testing possible solutions
Risk Assessment
Narrowing down the root causes
Root Cause Statement
CAPA Step 5: Implementative, Verification and CAPA closure
Implementation Phase
Implementation Plan
Creating Action Item for Solution implementation
Action Item Completion Verification
Verification of effective of CAPA
CAPA Closure