Process Validation and Qualification, Including Validation Methods

Comprehensive Validation Training: Facility Qualification, Process & Analytical Method Validation for Global Compliance

This course provides training and practical tools for, facility/equipment qualification, process validation and analytical method validation, including reference to international regulatory guidances from ICH, FDA, EMA and elsewhere. The training will also incorporate facility/equipment qualification, process validation and validation of analytical methods for requirements in Europe, US and elsewhere, including ICH. 

 

Interested in process validation & qualification training for your team? Contact us today. 

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Duration
2 days
CPD Hours
14 hrs
Locations
  • Reading (RSSL)

Who Should Attend

 This course is suitable for those working in most pharmaceutical companies (e.g., those producing novel medicines, generics manufacturers, suppliers/contract manufacturers, etc.) and is applicable to scientists, engineers, process validation/qualification professionals working in development, manufacturing, quality, engineering, validation and other related support functions.

Key Topics

During this two-day course the following topics will be addressed: 

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    Why validate? 

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    International regulatory requirements, e.g. US, EU & elsewhere 

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    Science and risk-based approaches 

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    The three stages of the validation life cycle (Ref FDA & EU) 

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    Understanding product and manufacturing process requirements 

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    Importance of control strategy 

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    Application of Quality Risk Management 

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    Readiness 

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    Process validation 

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    Determining the number of validation batches 

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    Qualification of equipment and utilities 

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    Maintaining control of product over its life cycle, including monitoring  

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    Analytical method validation 

Learning Outcomes

By the end of this course, you will: 

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    Understand regulatory requirements in EU, US and internationally for process validation, qualification and analytical methods 

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    Understand the three-stage approach to process validation and its applicability internationally 

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    Be able to apply tools and techniques to help clarify validation deliverables 

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    Appreciate the importance of science and risk-based approaches to validation and alignment to ICH Q8, Q9 and Q10 

Meet your expert tutors

Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

Bruce Davis (2)

Bruce Davis

An experienced tutor, Bruce understands the importance of engaged, active learning. Focusing on patient safety, Bruce ensures his sessions have a solid scientific approach, providing practical insights and real-world application. Having run his own consultancy for 15 years, Bruce specialises in risk-based topic areas including Quality Risk Management, Quality by Design, process validation / qualification and technology transfer.
Frequently asked questions

If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.

What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Useful and well delivered

The training was very interesting with useful practice and exercises, delivered correctly by the tutors.
Lukasz Megger
BCM Fareva - Validation Technologist

Thoroughly enjoyed

I really enjoyed the Process Validation and Qualification course, with Bruce Davis providing deep knowledge and engaging anecdotes.
Tarek El Abed
ICE S.p.A.

Engaging and knowledgeable tutor

The lecturer (Bruce) was very engaging and knowledgeable, he made sure that he met individual needs and responded to questions raised. Each attendee came from a different background and we each had individual reasons for being on the course. By making the material applicable to our situations we felt included - it wasn't just reading from a textbook but more applying the knowledge to our workplaces.
Maggie Cooper
Cooper Radioisotope Solutions - Qualified Person

Filled my knowledge gap

I learned a lot and enjoyed the opportunity to fill the knowledge gap I had before training.
Anonymous
Production and Supply Chain Business - Validation Officer

Adapting learning to my own requirements

The trainer (Bruce) was knowledgeable on the subject and encouraged interaction among the delegates. All delegates had different backgrounds so by encouraging discussion I was able to learn from other's experiences and see how that could adapt to my own requirements. Bruce was very knowledgeable, able to answer our questions and explain the course content in a way that was easily understood.
Terri-Nichol Carter
Wren Laboratories Ltd - Supply Chain and Project Coordinator

Book Your Place

Process Validation and Qualification, Including Validation Methods
09 Sep 2025
-
Reading (RSSL)
£1170 excl VAT
Istock 1044232264

Bespoke Training

We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.

Bring this course in-house Bring this course in-house

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Why choose RSSL?

As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community