Good Manufacturing Practices (cGMP) - Intermediate

cGMP – Equipment, Validation, Complaints and Self Inspection

In this course we will discuss why we need to adhere to good manufacturing practices from a Quality Management System perspective, we will discuss GMP in relation to changes to equipment and documentation, qualification and validation, complaints and product recalls and self-inspection.

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CEU Credits: 0.1
Course Code: ELM-203
Duration: 30 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 08/23/2021

Curriculum for this course

Overview
Learning objectives
Who should take this course?
Program introduction
Module Oveview
Overview
Whats is GMP?
What is cGMP?
World Health Organization (WHO)
Why GMP?
Overview
Equipment
Balances
Utilities
Documentation
Change Control
Overview
Definitions
Qualification Vs Validation
Risk Assessment
Types of Validation Documentation
Overview
Complaints & Product Recall
Classification of Defects - Critical
Classification of Defects - Major
Classification of Defects - Minor
Product Recall Procedures
Overview
Self-Inspection
Frequency
Self-Inspection Team
Self-Inspection Approach (Systems)
Self-Inspection Approach (Areas)

Conclusion

Final Exam

Certification

Updated to improve media quality and resolve quiz functionality
V2.0

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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