CEU Credits: 0.1
Course Code: ELM-123
Duration: 10 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V3.0
Effective Date: 11/03/2025
Curriculum for this course
Course Introduction
Determine the basis for the audit
Audit purpose and goals
Audit standards
Audit scope
Audit feasibility
Team roles and responsibilities
Defining the audit: Anya’s team
Reviewing records
Preparing the audit plan
Communicating the audit plan
Preparing work documents
A prepared team
Test Your Knowledge
v3.0 Major update on 02/09/2026 This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well.
v2.2 Minor update on 03/04/2025. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v2.1 Minor update on 08/01/2024 to remove an extra quiz question unrelated to this course that caused the learner to be asked 11 questions instead of 10.
v2.0 Major update on 07/19/2022 to update name from “FDA Inspection Readiness – Part 1” to “How to be an Effective GMP Auditor – Part 2”, redesigned course with new Articulate Storyline player, added new review activities and final exam question to align with learning objectives and updated glossary links.
v1.0 Course released in 2021