CAPA Mastery Badge
Why CAPA Mastery? Failures top the charts in shutting down your operations, decreasing efficiency and increasing risk of regulatory enforcement. It is time to prevent the failures and increase the assurance of every product you release. This course will equip you with the tools you need to establish strong corrective and preventative actions, linked to actual root cause.
Who Should Enroll? The CAPA Mastery Badge is intended to be an advanced course and is recommended for medical device and pharmaceutical industry professionals who have previous experience with investigation writing.
What Will I Learn? Below, you will find each class listed with the Learning Objectives, Expert Instructors, and total course time needed to complete the program. You will learn from many case studies and be armed with tools to understand, develop, and evaluate CAPA effectiveness.
Digital Badge? Once you successfully complete the on-demand program, you will be awarded a Certificate of Completion and a Digital Badge that you can share on LinkedIn!
Meet Your Expert Instructors!
The Curriculum:
CAPA Mastery Badge: 6 Classes. 7 Videos. ~4.5 hours [.45 CEU]
Class 1: Finding Root Cause
Instructor: Bill Farmer (Merck)
Learning Objectives:
1. Learn how to identify poor root cause identification
2. Understand the importance of finding true root cause
3. Understand the link between root cause identification and effective CAPA development
Class 2a: Overcoming Barriers - Part 1
Instructor: Marla Phillips (Pathway)
Learning Objectives:
1. Learn examples of pressure that can cause poor root cause identification.
2. Understand how lack of experience can result in poor root cause identification.
Class 2b: Overcoming Barriers - Part 2
Instructor: Marla Phillips (Pathway)
Learning Objectives:
1. Recognize psychological factors that can impede successful root cause identification.
2. Learn ways to overcome barriers to good root cause identification.
Class 3: Developing a Strong CAPA
Instructor: Bill Farmer (Merck)
Learning Objectives:
1. Recognize the Difference between Corrections, Corrective Actions and Preventative Actions.
2. Measure the Strength of your CAPA.
3. Understand Risk Factors to determine the CAPA strength needed.
4. Keep the “line of sight” from problem, to cause, to CAPA
Class 4: When CAPA do not Address the System
Instructor: Ann Moody (CSL Behring)
Learning Objectives:
1. Learn the impact of “retraining” employees.
2. Understand that Human Error is not a root cause. 3. How to properly address failures that resulted in a human error, and prevent recurrence.
Class 5: CAPA Effectiveness
Instructor: Bill Farmer (Merck)
Learning Objectives:
1. Learn how to breakdown the CAPA development process into steps
2. Understand the different levels of assessing CAPA effectiveness
3. Realize the importance of Knowledge Management, and how to capture this knowledge
Class 6: CAPA Case Studies
Instructor: Bill Farmer (Merck)
Learning Objectives:
1. Reinforce your learning on how to develop SMART CAPA and verify effectiveness.
2. We will review 3 scenarios
Pricing for On-Demand Badge:
How Will You Access the Course?
All Badge Courses are on-demand and are accessed through Pathway’s Learning Management System - Canvas.
You will receive an email invitation from Canvas (notifications@instructure.com).
You will create a Canvas log-in used for all Badges you take through Pathway.
In Canvas, you will complete all classes in sequential order. After completing a quiz at the end of each class, the next class will be made available to you.
After completing your course, you will receive your Certificate of Completion, which you can share as a Digital Badge on LinkedIn!
Interested in More? Quality Operations Forum
for Year Round Learning!
If you are a Site or Corporate Quality Professional, you are invited to join our Quality Operations Forum.
You will have many opportunities throughout the year to learn from your global peers, Chief Quality Officers and experts from our industry and beyond.
The purpose of the forum is to support you in proactively implementing successful practices gained through a vibrant network of global peers collaboratively addressing contemporary and complex challenges.
60+ World Cafe and External Intelligence meetings throughout the year are included!
Questions? Please contact Michelle Rich, our Director of Corporate Programs with any questions you might have.