See Course Price
Key practical information:
- Typically delivered as 12hrs/week for 10 weeks – BUT a fast track option can be chosen to meet your more urgent business needs (this involves delivery of the full program over a shorter timescale, with full support from our course delivery team)
- Fully flexible online schedule – all learning can be done at a time and place that suits each participant. There are NO in-person elements and NO fixed class times
- Each learner is given a dedicated course leader who checks in with their progress and follows up at the end of every week. This greatly increases the likelihood of a learner sticking to their schedule and finishing the program when expected
- Your team can join 3010 learners
Why choose GetReskilled for your CSV training?
We are an award winning specialist training provider for the pharmaceutical and medical device industries and we have a 10-year track record of delivering this specific program ONLINE.
We’re not interested in delivering short, surface-level CSV training – the type where everyone gathers in a hotel for a day or two.
We believe that detailed course materials that can be revisited time and time again, alongside worked examples and an assignment that truly puts what’s been taught into practice, is the best way to equip professionals with the skills and confidence they need to take on CSV responsibilities within this regulated industry.
For more information about our team and our company, visit our About Us page.
This course is right for your team if…
Specifically, your team will learn…
- The key FDA and international regulations (EudraLex Volume 4 — Annex 11, ICH, WHO) and guidance regarding CSV and which apply to your company
- How the CSV process fits into the Software Life Cycle and the purpose of each validation deliverable
- The principles of software quality assurance and how to manage the auditors’ expectations around its key components
- The software validation life cycle from design, through construction, installation, and live start-up
- The regulations governing the use of electronic records and signatures in a regulated environment.
- The methodology and implementation model for a risk-based approach to CSV
Learners all produce a number of deliverables throughout the course, including…
- Determine the end-user supplier activities during the lifecycle of a computerized system
- Identifying where they would use risk-based decision-making throughout the lifecycle of a computerized system
- Preparing a configuration management process flow diagram and identifying where to use change control
- Defining the content of typical logs and accompanying records for both incident management and corrective and preventive action (CAPA)
- Completion of 8-question booklets (one for every week of content) that summarise what was learned that week, to ensure they retain and understand the information
They will also write a 6,000-word technical report on a GxP computerized system application relevant to your business.
They will outline the following:
- Identify and describe typical business and GMP functions
- Schematically represent typical architectural components
- Describe a general approach to achieving compliance and fitness for intended use over the entire lifecycle.
- Concept
- Project
- Operation
- Retirement
This report will demonstrate:
- Their understanding of how the electronic data from the system is managed to make sure it is transparent, robust and tamperproof, and that it is stored so that it stands the test of time
- That the systems and procedures have been put in place to ensure that nothing crashes, no data is lost and that the necessary ERES considerations have been included
As you can see, the final assignment really does test each learner’s understanding and ability to implement CSV (whether that’s running an in-house project or knowing what questions to ask consulting firms and vendors).
And take the following skills and knowledge back to work…
- Be able to apply the FDA and international regulations to current projects
- Use Risk-based decisions when making an assessment to see what software does or does not require validation, ensure critical risks are identified and the correct level of validation is carried out
- Create key validation deliverables, including validation plans, requirements specifications, test plans, validation tests (IQ, OQ, PQ), trace matrices, test summaries, and validation reports
See Course Price
Minimum Entry Requirements
“You don’t need to be able to write code or have a computer science background to work in computer system validation”
However, participants must have solid experience using at least one GxP computer process and understand its functional layout.
In addition…
This program is highly specialized so they MUST have a solid understanding of Good Manufacturing Practices (GMPs) rules, regulations and guidelines.
AND they are any of the following…
- Validation Engineer/Specialist or Senior Validation Manager
- PhD, Masters or Degree in Biochemistry, Microbiology, Molecular Biology, Lab/Science, etc
- Automation, Control/Instrumentation, Process, Chemical, Manufacturing, etc Engineer or Technician
- Quality Assurance or Quality Control Technician or Specialist
- Metrology, Maintenance Engineer, Technician or Specialist
- Front/Backend Developer
- Not sure if your team member meets the minimum requirements? Chat to our Course Director
NOTE: If they don’t have a solid understanding of GMP rules, regulations and guidelines, they need to start with our 6-Week GMP Training For Beginners in the Pharmaceutical Industry. (There’s a special price reduction for this GMP program if taken together with our CSV course. Contact us for details)
10 Week Class Schedule:
You’ll find full details of the class schedule below.
It’s typically delivered as a 10 week programme with approximately 12 hours of work per week. Each participant receives weekly check-ins with their course coordinator to make sure they’re keeping up with the workload.
BUT a fast track option can be chosen to meet more urgent business needs. This involves delivery of the full program over 10 days with full support and daily check-ins from our course delivery team.
Delivered by a Practicing Industry Expert
Dr. Joe Brady
Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled
Dr. Joe Brady is a full-time practicing Validation Lead and an assistant lecturer with Technological University Dublin (TU Dublin), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer and highly experienced in competency-based training. He designs and prepares educational modules and full academic courses ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.
He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over twenty years of project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.
Hear From People Who’ve Taken This Course

Ken O’Keeffe
“Interesting and Helpful in my Current Role”
“I have found the Computer System Validation course to be both interesting and helpful in my current role. The individual sections of the course are easy to follow. The delivery of the course is really straight forward. During the course there has been times when I have been busy with work and have not been able to study. The structure of the course allows me to be flexible in my study.”

Giorgia Romeo
“I Would Highly Recommend This Course”
“I would highly recommend anyone wishing to gain an education in the Computer System Validation sector to do this course. For me it has been very useful studying on-line in order to do the course in my own time. Lessons are very clear and the assignment deadlines make you disciplined to meet the deadlines set.”

John Ryan
“The Course Material is Concise and Interesting”
“The professionalism and passion of the lecturers comes across in the tutorials which gives the student confidence and encouragement to keep on top of the course. The course material is concise and interesting. The timing of the release of the lessons is perfect, the student moves at a comfortable pace, one step at a time.”
If you’re spending money on employee training, make sure you choose one they’ll finish!
With every GetReskilled ONLINE program;
- We use one centralized platform (Moodle) where learners can log into their classroom anytime. Each session, they’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires them to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime.
- Working schedules are unpredictable so we offer flexible delivery. Learners can slow down, speed up or pause the delivery of the program depending on their current workload.
- We only release one week’s worth of material at a time and then MANUALLY check activity logs at the end of every week to make sure that learners are keeping up with work.
- Every learner has a dedicated course leader who will email or telephone if it looks like they’re starting to fall behind. The course leader will work with them to develop a study plan to get them back on schedule and finish the course.
This all helps us to spot any potential issues early and helps learners to successfully complete the program.

Price
$899/month
For 3 months
Or $2,499 in Advance
10 Day Fast Track Option
$3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save $2,499
€799/month
For 3 months
Or €2,299 in Advance
10 Day Fast Track Option
€3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save €2,299
£699/month
For 3 months
Or £1,999 in Advance
10 Day Fast Track Option
£3,499
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save £1,999
Price
€799/month
For 3 months
Or €2,299 in Advance
10 Day Fast Track Option
€3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save €2,299
$899/month
For 3 months
Or $2,499 in Advance
10 Day Fast Track Option
$3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save $2,499
£699/month
For 3 months
Or £1,999 in Advance
10 Day Fast Track Option
£3,499
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save £1,999
Price
£699/month
For 3 months
Or £1,999 in Advance
10 Day Fast Track Option
£3,499
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save £1,999
€799/month
For 3 months
Or €2,299 in Advance
10 Day Fast Track Option
€3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save €2,299
$899/month
For 3 months
Or $2,499 in Advance
10 Day Fast Track Option
$3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save $2,499
Got More Questions?
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Or chat with us via the blue chat bubble in the bottom right corner of the page. We’re always happy to help!