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About

The Qualification & Validation Training Course by Whitehall Training provides a comprehensive foundation in GMP-compliant validation practices, focusing on ensuring that pharmaceutical processes, systems, and equipment consistently deliver quality products. The course covers core concepts such as validation principles and regulatory expectations (FDA, EU GMP, WHO), types of validation (prospective, concurrent, retrospective, revalidation), and the full equipment qualification lifecycle (DQ, IQ, OQ, PQ). It also includes the FDA three-stage process validation model, validation master planning, protocol and reporting practices, and essential pre-validation activities such as risk assessment and system boundary definition. Additional topics include cleaning validation, computer system validation (CSV), analytical method validation, and change control with revalidation requirements. Emphasis is placed on lifecycle validation, documentation integrity, risk-based approaches, and continuous process verification. The course integrates practical applications such as developing validation protocols, performing qualification activities, and managing deviations and changes, all aligned with global GMP regulations and industry best practices.

Course Syllabus

  1. What is Validation?

  1. The Need for Process Qualification & Validation

  1. Scope & Importance of Validation

  1. Major Advantages of Validation

  1. Types & Methods of Validation
  2. Selecting the Right Validation Approach

  1. Activities Before Commencing a Validation Project

  1. Validation Master Plan VMP

  1. Basic Concepts: Equipment Qualification Framework
  2. IQ/OQ/PQ in a Tablet Compression Suite

  1. The FDA 3-Stage Process Validation Lifecycle

  1. Validation Protocol and Validation Report

  1. Cleaning Validation
  2. Cleaning Validation Failure — A Real Lesson Learned

  1. Computer System Validation CSV

  1. Analytical Methods Validation
  2. Change Control & Revalidation
  3. Change Control: When Revalidation is Non-Negotiable
  4. What Every GMP Professional Must Know

Course Benefits

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Fully compliant

This course follows the guidance of Annex 13 of the European Commission's GMP guidelines

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Certified

All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.

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Affordable

Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.

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Time-saving

Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.

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Reliable and trustworthy

This course was written by McCarthy Consultant Services Inc (Canadian specialists in regulatory work to support the global pharmaceutical, biotechnology, medical device, food, natural health products and cosmetic industries). You will also stay up to date with any legislative changes in GMP relating to IMPs as our training courses are constantly monitored, reviewed and updated.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

Learner Rating & Reviews

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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...