CAPA Mastery Badge - Advanced

Welcome to the CAPA Mastery Badge.

Strong Recommendation: Please complete the Investigations Courses (Basic and Intermediate) before participating in this badge. These investigations classes are also included in the Full Risk and Failure Analysis course.

You will find each class listed below with the Learning Objectives, Instructor and link to the Course Content: video, slides, note-taking worksheets. This program is intended to be an advanced topic for those who have already completed the Investigation Series (as a standalone series, or as part of the Quality Science Education full courses). The classes are taught as if the listener has experience in conducting investigations and developing CAPA. We hope you enjoy this program!

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Certificate of Completion?

To earn a Certificate of Completion:

  1. Watch the videos on this page

  2. Use the note-taking worksheets available in each class

  3. Click the "Take the Certificate of Completion Quiz" button

  4. Complete quizzes related to each video

You'll have multiple attempts to pass each quiz if needed—our goal is for you to learn, not to be penalized. Upon successful completion of the program, you will receive a Certificate of Completion.

Selecting Your Language Preferences

To select your language preference for Audio and Closed Caption Subtitles, use the settings wheel when you open the class video. Select “CC/Subtitles” and “Audio” and scroll to find the language you wish to listen to.

Technical Support

If you need technical assistance, or have feedback related to these classes, please complete the following form which will be sent immediately to our Pathway Team. You will be contacted within 1 business day regarding questions you have: Technical Support Form

Course Evaluation

Please complete an evaluation of any course you take through this Corporate Membership Site. Your insight is invaluable, and will help ensure the content is accurate, up-to-date and relevant: Course Evaluation Form

 

CAPA Mastery Badge: 6 Classes. 7 Videos. ~4.5 hours [.45 CEU]

Take the Certificate of Completion Quiz
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Class 1: Finding Root Cause (Multi)
Class 1: Finding Root Cause (Multi)

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

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Class 2a: Overcoming Barriers - Part 1 (Multi)
Class 2a: Overcoming Barriers - Part 1 (Multi)

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.

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Class 2b: Overcoming Barriers - Part 2 (Multi)
Class 2b: Overcoming Barriers - Part 2 (Multi)

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.

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Class 3: Developing a Strong CAPA (Multi)
Class 3: Developing a Strong CAPA (Multi)

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

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Class 4: When CAPA do not Address the System (Multi)
Class 4: When CAPA do not Address the System (Multi)

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.

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Class 5: CAPA Effectiveness (Multi)
Class 5: CAPA Effectiveness (Multi)

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

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Class 6: CAPA Case Studies (Multi)
Class 6: CAPA Case Studies (Multi)

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

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