Good Manufacturing Practices – Equipment, Validation & Complaints

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: Changes to Equipment and Documentation
Overview 45 secs
Equipment 2 min 19 secs
Balances 1 min 19 secs
Utilities 2 min 31 secs
Documentation 1 min 52 secs
Change control 1 min 23 secs
Module 2: Qualification and Validation
Overview 2 min 23 secs
Definitions 1 min 18 secs
Qualification Vs Validation 2 min 43 secs
Risk assessment 2 min 03 secs
Types of validation documentation 1 min 52 secs
Module 3: Complaints and Product Recalls
Overview 1 min 41 secs
Complaints and product recalls 2 min 52 secs
Classification of defects – critical 1 min 52 secs
Classification of defects – major 1 min 39 secs
Classification of defects – minor 1 min 59 secs
Product recall procedures 2 min 10 secs
Module 4: Self Inspection
Overview 1 min 21 secs
Self-inspection 2 min 21 secs
Frequency 1 min 10 secs
Self-inspection team 2 min 30 secs
Self-inspection approach (systems) 1 min 12 secs
Self-inspection approach (areas) 2 min 10 secs
Review activity 5 mins
Conclusion 2 mins
Conclusion
Final Exam
Certification
Author:

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