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. 

Read further course information Read further course information
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. 

Yes, the Introduction to Validation course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details. 
Places will be available for you to book unless it states ‘Full’ next to your chosen Introduction to Validation course date. When this occurs, we operate a waiting list service. 
Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems. 
You will need to first register yourself on our booking system by selecting the Introduction to Validation course date that you wish to book your colleagues onto, then:

 - Add the number of people you wish to book onto the course
 - Register yourself as the booker and complete the fields accordingly
 - Add the details of those you wish to book for
 - Complete your order. 
You will receive an automated email confirming your booking details for the Introduction to Validation course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included.
Usually, this 1-day Introduction to Validation course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000.
Our online Introduction to Validation course begins at 09:00am, although we request that you login at 08:30am to ensure any technical glitches can be resolved before the start time. Please review your course confirmation email to double check the exact start time of your specific course.

Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system. 
Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you. 
Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address. 
Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email. 
As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage.
Please see our '
minimum requirements' document for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test. 
Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees.

All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK.
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
£ 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.

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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