An Introduction to Process Validation – Part 1

Description:

In this course you will learn about general terms used in process validation. We will explain why processes are validated, and will review regulations associated with process validation. It will also give you an insight on safety, business and regulatory benefits of performing process validation. This will be followed by a look at current validation and qualification practices and expectations and how these are now being globally harmonized.

Curriculum for this course:
Introduction
Overview 1 min 21 secs
Course structure 1 min 34 secs
Learning objectives 1 min 23 secs
Who should take this course? 1 min 39 secs
Course modules 2 mins 12 secs
Module 1: Introduction
Overview 1 min 32 secs
Fundamental terms 2 mins 14 secs
General sayings 1 min 18 secs
Module 2: Why Validate Processes
Overview 1 min 41 secs
Why validate processes 1 min 30 secs
Regulations 2 mins 51 secs
Regulations (Continued) 1 min 18 secs
Benefits 1 min 30 secs
Safety 1 min 49 secs
Business 2 mins 10 secs
Regulatory 1 min 49 secs
Validation and qualification 1 min 30 secs
Harmonization 2 mins 01 sec
Module 3: Initiation of Validation
Overview 1 min 30 secs
Validation 2 min 10 secs
Validation versus verification 2 min 49 secs
What is process validation 2 min 31 secs
What is validated 2 min 33 secs
What processes to validate? 1 min 58 secs
Determining whether to validate or if verification is sufficient 1 min 49 secs
Who validates 1 min 39 secs
What does the team do? 1 min 50 secs
When to validate? 1 min 30 secs
Prospective validation 2 mins 11 secs
Concurrent validation 2 min 30 secs
Retrospective validation 2 mins 10 secs
Types of process validation in Europe 1 min 49 secs
When to validate/revalidate 1 min 15 secs
Design review 1 min 25 secs
Process validation study 1 min 05 secs
Module 4: Validation Master Plan
Overview 2 min 09 secs
Validation master plan 1 min 33 secs
Whom does the VMP help 2 min 51 secs
VMP planning 1 min 23 secs
Contents of a master validation plan 2 min 22 secs
Contents of the validation master plan 2 min 21 secs
Approaches to the qualification of equipment 1 min 48 secs
Approaches to the qualification of legacy equipment 2 min 10 secs
The validation plan (qualifications) 1 min 22 secs
Conclusion
Final Exam
Certification
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