Internal Auditor Training for Manufacturers of Active Pharmaceuticals Ingredients (API)

A summary of modules within this course include:

• FDA CFR part 211 cGMP for Pharmaceuticals & additional EU GMP Part II requirements
• Audit Terminology
• Principles of Auditing
• Audit Program Management
• Audit Process
• Audit Life Cycle
• Audit Scope, Objectives & Criteria
• Auditee, Observer & Guides
• Audit Initiation & Preparation
• The Audit Plan
• Audit Documentation
• Audit Findings & Reporting
• Audit Follow Up

Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.

In order to successfully complete this course, each Learner will need to:

• Maintain 100% attendance and achieve 70% or higher in the continuous assessments

If you are completing this training virtually, the following applies:

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.