Good Manufacturing Practices (cGMP) - Intermediate

Audit Closure

After a GMP audit of Sorantics Pharmaceuticals, Anya’s team is ready to write their report and initiate the close-out. Follow them as they catalog findings, consider what to include in the report and what to leave out, contemplate a follow-up audit and possible escalation, and walk through the final stages that lead to the closing of the audit file with precision and purpose. In this course, you’ll explore this process and learn how to help companies transform audit findings into actionable recommendations to ensure regulatory compliance and continuous improvement.

CEU Credits: 0.1
Course Code: ELM-125
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 04/03/2025

Curriculum for this course

Anya’s Team
Report Tour: Basics
Report Tour: Findings
Audit Findings and Quality Implications
Finding or Outcomes?
Types of Findings: Minor Findings
Types of Findings: Major Findings
Types of Findings: Critical Findings
Report Tour: Final Sections
Clarity and Concision
Active Voice, Organization, and Objectivity
What To Put In And What To Leave Out
Review, Approve, and Distribute
Follow-Up Audit
CAPAs
Escalation
Final Report Findings
Final Audit Report Documentation
Management Review and Continuous Improvement
Closure Communication
A Quality Ending
Test your Knowledge!
v1.0 Course released on 08/26/2025

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