Validation in ongoing process review to ensure that the manufacturing process leads to final products of the desired quality. Validation goes hand-in-hand with documentation and is part of current Good Manufacturing Practice (cGMP) guidelines. This process seeks to ensure that all systems are functioning properly and capable of recreating the target quality hence, validation must be consistently done as long as products are being manufactured. This is an introduction to the concept that covers its history, necessity, and goals. You will also learn about the different kinds of validation and proper documentation.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Introduction
Lesson 1: Definition of Validation
Lesson 2: Need for Process Qualification and Validation
Lesson 3: Scope of Validation
Lesson 4: Major Advantages of Validation
Lesson 5: Types/Methods of Validation
Lesson 6: Activities to be Undertaken Before Commencing Validation Project
Lesson 7: Validation Master Plan
Lesson 8: Basic Concept of Process Validation
Lesson 9: The Stages of Process Validation
Lesson 10: Validation Protocol Report
Lesson 11: Cleaning Validation
Lesson 12: Computer System Validation
Lesson 13: Analytical Methods Validation
Conclusion
Glossary
Quiz
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