An Introduction to Process Validation – Part 2

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Description:

In the second part of our program on process validation, you will learn in more detail, the different steps that constitute process validation. We will look at the qualification of equipment and the steps that need to be performed during a validation study. This will also include a discussion of the validation protocol, how it should be written and approved. Finally, we discuss the differences between the traditional and the new life cycle approach.

Curriculum for this course:

Introduction

Overview	1 min 41 secs
Course structure	2 mins 14 secs
Learning objectives	1 min 18 secs
Who should take this course?	1 min 49 secs
Course modules	1 min 49 secs

Module 1: Equipment Qualification Stages of Process Validation

Overview	1 min 50 secs
Qualification of equipment	2 mins 10 secs
Design qualification	1 min 15 secs
User requirement specification	1 min 25 secs
Functional requirement specification	2 min 22 secs
Operational requirements	1 min 48 secs
Vendor qualification	1 min 22 secs
Installation qualification	1 min 23 secs
Installation qualification protocol	2 mins 10 secs
Operational qualification	1 min 28 secs
Operational qualification protocol	1 min 31 secs
Performance qualification	1 min 52 secs
Review activity	1 min 55 secs

Module 2: Process Validation

Overview	2 min 51 secs
What is process validation?	1 min 30 secs
The stages of process validation	2 min 21 secs
Stage 1: Process design	1 min 38 secs
Stage 2: Process validation	1 min 25 secs
Stage 3: Continuous process validation	1 min 29 secs
Review activity	1 min 49 secs

Module 3: Traditional Approach to Process Validation

Overview	1 min 30 secs
Traditional Approach	1 min 49 secs
Modern Approach to Process Validation	1 min 50 secs
Traditional vs New Life Cycle Approach to Validation	2 min 31 secs
Quality Risk Management	1 min 49 secs
Quality by Design	1 min 09 secs
Quality by Design (Continued)	1 min 41 secs