Our most flexible course ever (with a VERY special offer)

Have you been considering a new career in Computer System Validation (CSV)? Are you a bit overwhelmed at the thought of trying to fit a course into your current schedule?

If you’re looking to start a career in Computer System Validation (or take on projects that require it), you’re in the right place!

If you’re not, click on the blue chat bubble at the bottom of the screen to chat to us and we’ll help you find the ideal course for you.

Main Course Features of the CSV course

This programme delivered entirely online
Your materials are available 24/7 and there are no fixed class times so you can study where and when you want
Learn how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework and ensure compliance with FDA’s CFR Part 11, EU Annex 11 or other regulatory guidelines.

Our graduates work for the world’s biggest pharma and medical device companies

Our most flexible course ever (with a VERY special offer)

Have you been considering a new career in Computer System Validation (CSV)? Are you a bit overwhelmed at the thought of trying to fit a course into your current schedule?

If you’re looking to start a career in Computer System Validation (or take on projects that require it), you’re in the right place!

If you’re not, click on the blue chat bubble at the bottom of the screen to chat to us and we’ll help you find the ideal course for you.

Our graduates work for the world’s biggest pharma and medical device companies

Main Course Features of the CSV course

This programme delivered entirely online
Your materials are available 24/7 and there are no fixed class times so you can study where and when you want
Learn how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework and ensure compliance with FDA’s CFR Part 11, EU Annex 11 or other regulatory guidelines.

What is our Special Offer for this Brand New Subscription Track?

10 free days of study every single month!

Cost: €449 per month (each “month” of your subscription will last 40 days instead of 30 days)

That’s a 33% saving!

What is the benefits of this deal:

You study at entirely your own pace! So if you’ve got some free time coming up, you can move more quickly through the course
Or if you’ve got a hectic schedule or unpredictable availability, you can take as long as you need to complete the materials and get your certificate with absolutely zero pressure.
Whatever pace you choose to study at, you’ll have a named Course Coordinator as your point of contact and with you every step of the way
Only €449 a month (ongoing until you complete your certificate or cancel your subscription)

If you can identify with any of these reasons, then this programme is for you

People who want to test the water without committing to the full course fee – maybe it’s been a LONG time since you studied, you’re not feeling confident or maybe you’re worried about whether you can keep up with the technical module… whatever your doubts, starting the course via a subscription model is a great way to test the water without committing to the full course fee. You can cancel your subscription at any time, no questions asked.

People who have some extra free time coming up – maybe it’s the end of year holidays, redundancy from your current role, some annual leave allowance to use up… whatever the reason, if you’ve got some extra time to spare you’ve got a great chance to put it to use and get yourself a certificate faster that usual. And if you do that, you’ll even save yourself some money vs our Standard Track option.

People who want complete control over their studies – some people just want to spend as long as they want on their study materials without feeling pressure to study faster. If you want deadline-free learning, the Subscription Track could be perfect for you

People who have limited time or variable schedules – if you’re not the sort of person who can follow along with a typical course because your schedule changes from one week to the next, this is ideal for you. You study when you have the time and there’s no pressure to do coursework when you’re not available. You take the time you need and your certificate’s waiting for you when you get to the end.

Whatever Your Current Schedule – this CAN work for you

We only work with adult learners. It’s all we do so we’re really good at it…

You can study when and where you want – the course is delivered entirely online and there are no fixed class times, your materials are available 24/7
You’ll get a designated course coordinator to help keep you motivated and answer any questions you might have

Core content developed on a pharma engineering project

This program was developed on-site by a team of senior validation engineers, chemical engineers and automation engineers working within an engineering consultancy to train its own engineers and technicians.\

You’ll learn:

The Food and Drug Administration (FDA) regulations such as 21 CFR 211.68, 21 CFR 11, the international regulations (EudraLex Volume 4 — Annex 11, ICH, PICs) and guidance regarding CSV, and which apply to your company
How the CSV process fits into your Software Life Cycle and the purpose of each validation deliverable
The principles of your software quality assurance and how to manage auditors’ expectations around its key components
The software validation life cycle from design, through construction, installation and live start-up
The methodology and implementation model for a risk-based approach to CSV

You can view the full course syllabus here:
https://www.getreskilled.com/computer-system-validation-course/#Syllabus

Take the Following Skills Back to your Workplace

Be able to apply the FDA and international regulations to your 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 that the correct level of validation is carried out
Create key validation deliverables to take back into your workplace

You can head over to LinkedIn and find almost 800 previous students. Feel free to ask them questions or check out the types of jobs they have now. Click this link to go to LinkedIn

Hear from people who’ve taken this course

Shane Flynn

“I found the Computer System Validation course to be very well structured and detailed”

“All sections of the course were explained well and the online delivery allowed for a flexible study plan which was very beneficial when working alongside study. The end of module assignments targeted key points in the lectures which was useful when writing the final assignment. I found this course very useful in my current role and would highly recommend it to anyone looking to gain knowledge in Computer System Validation.”

Computer System Validation Training Program

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.”

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.

Frequently Asked Questions

What are the Terms and Conditions of this Subscription Deal?

1. The Courses for delivery under the Subscription Model will be available for 12-months from the commencement date of the Course.
2. To retain access to the Course there will be a monthly Subscription Fee of €499 per month, to be paid every 40 days from the initial date your payments started
3. The monthly Subscription Fee to the Course cannot be paused, and if it is not paid by the due date each month, then the Course will not be available until it is paid.
4. The monthly Subscription Fee may be cancelled at any time, and the Course will be closed permanently.
5. A student will have to start from the beginning of the same Course again if they have previously cancelled a Course, and not from where their previous Course was cancelled.
6. The Course expires after 12-months from the commencement date of the Course, and there will be no extensions beyond 12-months, and after this time the Course will be closed permanently.
7. New study materials will only be released to the student on submission of their completed Question Booklet and associated Workshops (if any) for their current Session.
8. The GetReskilled Course Co-ordinator will check-in with the student on submission of each completed Question Booklet and associated Workshops (if any) that are due for their current Session.
9. Courses for delivery under the Subscription Model are completely personal and are non-exchangeable for other Courses.
10. Courses for delivery under the Subscription Model are non-transferable to other people, and sharing of the Course amongst other people is prohibited, and will result in the immediate termination of your course.
11. GetReskilled reserves the right to cancel a monthly Subscription Fee to a Course if fraud is suspected in relation to the use of the Course.
12. The course remains the property of GetReskilled.
13. Any dispute or claim arising out of or in connection with a Course shall be subject to the non-exclusive jurisdiction of the courts of Ireland.
14. GetReskilled reserves the right to change the terms and conditions of the Subscription Model for a Course, with a corresponding modification of this document and notification of the student.

Can I have my employer pay for this?

Yes, a number of our students have their employers pay for this program.

What is the process if my employer wants to pay for this course?

We can invoice your employer (with or without a purchase order) for payment. First, you need to provide us with your employer details so we can prepare the invoice. You can share these details in our follow-up phone call or we can email you an outline of the information we need and have your employer respond.

Or you can pay by company credit card or bank transfer.

How is the programme delivered?

The programme is delivered entirely online. You will get your weekly programme materials and assignments in your online classroom. You will have access to the materials for at least 6 months after you have finished the programme. The notes are in a pdf and the questions are given in a ‘Word’ doc so you can save them on your computer. The video is the only part that you cannot save.

What does studying this course look like?

The course has 15 “sessions” of online content (10 if you qualify for an exemption).

In the Standard Track, you’ll study a session a week. In the Fast Track, you’ll study a session a day.

Each session of online content typically includes 6-10 topics.

Each topic includes:

Warm-up self-assessment question – to recap or activate any relevant prior learning
A video – these are typically 5-10 minutes long and deliver 80% of the course content
Set of course notes – these provide additional depth to the video content.
Post video self-assessment questions – to check how well you can recall this new material from memory. If you can’t answer these questions, you should revisit that topic’s learning materials. These questions are not marked by the course leader but you should really view them as sample interview questions, these are the sort of questions you’ll need to confidently answer to get a job in the industry.

Do I need to be online all the time?

No, you don’t. The online classroom is open 24 hours a day so you do not have to login at any particular time. We will give you a Username and Password on the day the programme starts which allows you round the clock access.

How do you keep track of my progress on the course?

We only release one session of material at a time. We then regularly check your activity logs to make sure that you’re managing to keep up with the work. This helps us to spot and help to solve any potential issues early.

I live in the UK/Europe/USA/Australia etc., can I still take this programme?

Yes, you can take it from anywhere you have a decent Internet connection.

What Track should I take?

This is entirely dependent on how much time you have available to study and how consistent/reliable that time is.

Standard Track

The Standard Track is the one that most students follow. It’s best for people with limited availability who are happy to be held accountable for studying to a timetable they decide at the start of the programme.

On this track you tell your Course Coordinator about any upcoming holidays or responsibilities that will reduce your ability to study in certain weeks and agree to those as breaks in your course delivery.

Once you start studying on this track, your Course Coordinator will check on your progress each week. They’ll recognise your progress and release the next week of work if you’re up-to-date. If you’ve fallen behind, they’ll be looking to address any barriers to your study schedule and get you back on track as soon as possible.

You can also speed up the rate of delivery if you wish. The most important thing is communication between you and your course coordinator.

In this track, you’ll have the option to pay the course fees in full at the start of the programme or to pay 4 equal monthly payments.

Fast Track

The Fast Track is best for people who have full time availability for 15 days (or 10 days with exemption). It doesn’t matter what your typical schedule looks like, if you have consecutive free working days (Monday – Friday) you can take the Fast Track.

You can choose your own start date from the day following your course fee payment, up to 3 months in advance.

You’ll be expected to study at the pace of one session per day.

With this track, you’ll be given priority access to your Course Coordinator. This means that they’ll prioritise checking for your submissions and releasing new materials (if previous submissions are up-to-date) at the start of every day.

Fast Track assignments are also given priority in correction. All Fast Track assignments are corrected within 1 week of submission (the standard correction of assignments takes up to 3 months). This means you’ll get your certificate significantly faster.

This is an intensive programme but one that realistically prepares you for an entry-level job in the Pharmaceutical Manufacturing industry as quickly as possible.

Subscription Track

The monthly Subscription Track is best for people with limited (or changeable) availability who want significant flexibility in their course delivery.

In this track you’ll pay each month until your course is completed.

You’ll have as much time as you need to complete each session. As soon as it’s complete, send your Course Coordinator an email and they’ll open up the next session for you within 24 hours.