cGMP – Equipment, Validation, Complaints and Self Inspection

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Description:

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.

Curriculum for this course:

Introduction

Overview	1 min 34 secs
Learning objectives	1 min 18 secs
Who should take this course?	56 secs
Program introduction	45 secs
Module Oveview	1 min 02 secs

Module 1: The Starting Line

Overview	45 secs
Whats is GMP?	2 min 19 secs
What is cGMP?	1 min 19 secs
World Health Organization (WHO)	2 min 31 secs
Why GMP?	1 min 52 secs

Module 7: Changes to Equipment & Documentation

Overview	2 min 23 secs
Equipment	1 min 18 secs
Balances	2 min 43 secs
Utilities	2 min 03 secs
Documentation	1 min 52 secs
Change Control	1 min 10 secs

Module 8: Complaints and Product Recalls

Overview	1 min 41 secs
Definitions	2 min 52 secs
Qualification Vs Validation	1 min 52 secs
Risk Assessment	1 min 39 secs
Types of Validation Documentation	1 min 59 secs

Module 9: Complaints & Products

Overview	1 min 21 secs
Complaints & Product Recall	2 min 21 secs
Classification of Defects – Critical	1 min 10 secs
Classification of Defects – Major	2 min 30 secs
Classification of Defects – Minor	1 min 12 secs
Product Recall Procedures	2 min 10 secs

Module 10: Self-Inspection

Overview	50 secs
Self-Inspection	1 min 10 secs
Frequency	1 min 02 secs
Self-Inspection Team	1 min 10 secs
Self-Inspection Approach (Systems)	1 min 15 secs
Self-Inspection Approach (Areas)	1 min 02 secs