Overview of Qualification and Validation

Validation and qualification (1)

Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through ourย certificate online checker. They can also be shared on Linkedin.


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. Therefore, 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.






  • Validation and GMP Go Hand in Hand!


Lesson 1: Definition of Validation


Lesson 2: Need for Process Qualification and Validation


Lesson 3: Scope of Validation


  • Importance of Validation


Lesson 4: Major Advantages of Validation


  • Assurance of Quality
  • Process Optimization
  • Reduction of Quality Costs
  • Safety


Lesson 5: Types/Methods of Validation


  • Prospective Validation
  • Concurrent Validation
  • Retrospective Validation
  • Revalidation


Lesson 6: Activities to be Undertaken Before Commencing Validation Project

  • The Validation Committee
  • Process Evaluation to Determine Validation Requirements
  • Identification of Systems and System Boundaries


Lesson 7: Validation Master Plan


  • Validation Master Plan
  • Contents of VMP


Lesson 8: Basic Concept of Process Validation


  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Prerequisite of Process Validation
  • Reason for Process Validation


Lesson 9: The Stages of Process Validation


  • Stage 1 โ€“ Process Design
  • Stage 2 โ€“ Process Validation or Process Qualification
  • Stage 3 โ€“ Continued Process Verification


Lesson 10: Validation Protocol Report


Lesson 11: Cleaning Validation


  • Choice of Cleaning Method
  • Measuring the Level of Cleanliness
  • Setting Limits


Lesson 12: Computer System Validation


  • Assessment of Computer Systems to Determine Validation Requirements
  • Hardware
  • Software


Lesson 13: Analytical Methods Validation


  • Change Control and Revalidation
  • Revalidation








Ellena Jefferson
Amita Joshi
Dr. Jefferson is a CAPA Manager. She serves as a Training and Quality Advisor with ICONIC plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Dr. Jefferson is a fixer who continuously strives for excellence as a way of life; not just as a job.


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