Introduction to Validation

Pharmaceutical Validation for Ensuring Patient Safety and Compliance with Eudralex Annex 15 Standards

Pharmaceutical validation is designed to help ensure patient safety through the thorough the validation of manufacturing processes, cleaning procedures, equipment and analytical methods.   

 

This course provides an overview of the concept of qualification and validation as described in Annex 15 to Eudralex Volume 4, covering the responsibilities and terminology (qualification, validation and verification).  

 

This training also addresses the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation, as well as the need for effective change and lifecycle management. The documentation and project management aspects of validation studies will also be examined. 

 

Interested in Validation training for your team? Contact us today. 

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Duration
1 day
CPD Hours
7 hrs
Locations
  • Online

Who Should Attend

This course will be of value to pharmaceutical professionals who require a greater understanding of GMP expectations of validation in today’s regulatory environment. This includes management, laboratory and manufacturing staff, as well as engineering personnel. 

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Key topics

This course includes the following topics: 

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    Basics of validation 

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    Planning validation and document 

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    Protocol preparation and completion 

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    Qualification protocols and reports 

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    Method validation process and cleaning validation 

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    Transport, packaging and utilities 

Learning Outcomes

By the end of the course you will: 

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    Understand the regulatory expectations 

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    Know how to evaluate validation and qualification requirements 

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    Be able to plan and document validation studies 

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    Understand the link to change management and ongoing lifecycle management 

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. 

John Spenn

John Spenn

John is a quality expert with over 25 years in the biopharmaceutical and life sciences industries. He has held senior roles in quality management, regulatory processes and validation (CQV) lifecycle for equipment, facilities, utilities, sterilisation and computer systems. Currently a Director at Dorset Quality Services, John provides validation and quality consulting.
What our clients say

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

What our clients say

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

Comprehensive overview of validation with real-world relevance

Very informative with real-world relevance; covered a lot in a single day, providing a broad understanding of validation types.
Anonymous
Valneva Scotland Ltd

Useful information which will be used by myself and my colleagues

It was extremely informative and the presenter/presentation gave a lot of useful details and information, which will be used by both myself and my colleagues. John Spenn had excellent knowledge and insight, with experience gathered over a number of years and covering all validation scenarios.
Anonymous
UK Vitamin Manufacturer

Book Your Place

Introduction to Validation
30 Apr 2025
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Online
01 Oct 2025
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Online
£590 excl VAT
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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

Further courses to consider

Cleaning Validation
From 10 Apr 1 day

Explore the issues and pitfalls you may experience when performing Cleaning Validation


£820 ex VAT
Virtual tutor-led
Process Validation and Qualification, Including Validation Methods
From 9 Sep 2 days

Gain the practical tools for validation including qualification and analytical method validation.


£1170 ex VAT
In-person

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