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Certification in eValidation – Get Answers to Your Most Important Questions

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The Certificate in eValidation is a 30-week online course that will give you the knowledge you need to specialize in the highly sought-after niche area of validation, within pharmaceutical manufacturing.

  • Acute shortage of Validation Professionals worldwide.
  • High paying jobs (30% above average)
  • A stand-alone programme designed to build your validation skills
  • Academically accredited (Level 7) by the Dublin Institute of Technology, Ireland
  • A stepping stone to our follow-on Degree Programme

Application Deadline: 10th October, 2018

Program Starts: 18th October

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Who Is This Course For?

The eValidation programme is typically suitable for:

  • People with a production, science, logistics, quality or technical background who are looking to make a mid-career change into the pharmaceutical or medical device industries.
  • People already working within the industries who want to specialize in quality or validation roles
  • People who have successfully completed our eBioPharmaChem course

At the end of the course, you would be able to take the role as Team Leader on a Validation Team.

Recognized prior learning (RPL) and experience will be always be taken into account. We assess every application on its individual merits. Contact us if you’d like to discuss this further.

What Is The Course Content?

There are 3 modules that make up the course:

Module 1 – Pharmaceutical Facility Design (VOMP 3006)

In this module, you will receive a strong grounding in the modern science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.

Module 2 – Planning a Validation Strategy (VOMP 3008)

This module will give you a broad understanding of how to develop a Validation Master Plan (VMP) for a typical product lifecycle and to prepare the Process Validation Protocol for presentation during a regulatory audit.

Module 3 – From URS to PQ – a Practical Validation Project (VOMP 3011)

This is a capability building experience where you will develop a P&ID and then back-engineer it into a URS (User Requirement Specification) which will be used to identify the key process measurements that will form the basis of the Performance Qualification (PQ) test script.

This link will take you to the full syllabus

Each module is 10 weeks long and the course has a variety of assignments (see below for more info). With your course login, you will have access to all course material for at least 6 months after completion.

How Is The Course Delivered?

All course learning is done online.

Modules 1 is delivered by Dr. Joe Brady on an online platform called Moodle. Don’t worry if you’ve never used it before, full instruction will be given.

Module 2 is delivered Professor Anne Greene, again via Moodle.  

Module 3 is run by Dr. Joe Brady, via Moodle and a series of webinars as it is an entirely project-based module.

What About My Certification?

Once you have completed all 3 modules, your work will be submitted to Dublin Institute of Technology exam board. You will be awarded your certificate once the exam board has reviewed and approved the submission.

Certificates are only issued twice a year by DIT, in February and September.  As a result, there will likely be a delay between you finishing your coursework and actually receiving your certificate. If you need written proof of your studies prior to this, contact your course advisor.

What Does A Typical Week Look Like?

The course is comprised of 3 modules.

Each module has 8 “Sessions” of online content, one per week.

Each session of online content typically includes 8-12 topics.

Each topic includes:

  • A video – these are typically 10-15 minutes long and deliver 80% of the course content
  • A set of course notes – these provide additional depth to the video content.
  • Two self-assessment questions – one before the new content to recap relevant prior learning; and one after the new content has been delivered, to help you assess how well you’ve taken on this new material. The purpose of these is to have you to consider what you have learned and identify any gaps in your knowledge. If you cannot answer these questions, you should revisit that topic’s learning materials. These questions are not marked by course advisors but you should really view them as sample interview questions, as these are the sort of questions you’ll need to able to confidently answer to get a job in the industry. It is extremely important that you take the time to consider them and write great responses.
  • A visit to the class discussion forum – after each topic you should spend some time on the class discussion forum where you can chat to other students about the topic, about any difficulties you had or to explore ideas further.

In total, you should plan for approximately 14 hours of study time per week.

You have 24/7 access to the online materials. We recommend creating a timetable that fits your studies into your schedule with any other commitments you have.

Each module concludes with an end of module assignment (see below details).

Your activity logs will be checked weekly by your course supervisor to ensure that you are keeping up to date with the course. If we see that you’re not, we’ll email or call you to discuss. This gives you an additional safety net and means that any possible issues are caught early.

This same person is the point of contact that you can proactively reach out with any questions or issues. You’ll be in regular contact with them throughout the course and will get to know each other very well.

What Are The Assignments Like?

The eValidation course uses several different types of assignment. Your course coordinator will contact you via the online learning platform or email to let you know when assignments have been released, and what the submission deadline is.

The assignments will sound extremely daunting before you start the course, however, they are very manageable and between the course content and additional research, you will be able to answer all of the assignment.

Module 1 – the assignment is comprised of 6 written questions which require answers that will take approximately 10 pages in total (not per question).

Module 2 – both assignments are case study based. After session 3, a 30% assignment is issued. You’ll be asked to review a document and apply your own knowledge to it. Your answer should be an essay of approximately 1,000 words. After session 8 you are given a 70% assignment which will require an essay of approximately 3,000 words.

Module 3 – this is a workshop driven module where you will develop a P&ID and then back-engineer it into a URS (User Requirement Specification). This will be used to identify the key process measurements that will form the basis of the Performance Qualification (PQ) test script.

Graded assignments are to be submitted via email AND hardcopy. You should also make sure you keep a copy for your own records.

Assignments will be reviewed at various points throughout the programme and given a provisional result. All results remain provisional until the Dublin Institute of Technology exam board has received and reviewed your complete course file.

What Support Do I Have While I Study?

Every trainee taking our eValidation programme is given a dedicated course advisor. This same person will be your point of contact from the point of enrolment to your graduation.

They will check your course activity weekly to ensure that you’re keeping up with the programme and will reach out via email or phone call if they notice you are falling behind. This gives you the opportunity to discuss any issues you are having.

Even if you’re keeping up just fine, they’ll check in with you at regular intervals. You can also reach out to them at any point to discuss any questions or queries you have.

You will also have access to an online class discussion forum. This is a place where you are your classmates can discuss the course, your experiences and exchange ideas. The forum is monitored so if technical questions arise, they can be answered definitively. But other than that, the forum is a place for the class to discuss whatever they want.

What Kind Of Job Would I Be Suitable For After?

After this course, you will have the knowledge necessary to begin a specialist career in validation and quality. The specific jobs you would be suitable for will depend on your previous work experience – you can check out this article for more information.

Are There Opportunities For Further Study After eValidation?

eValidation is a comprehensive standalone CDP certificate programme. However, when combined with our eBioPharmaChem programme, it can also act as a stepping stone to our BSc in Manufacture of Medicinal Products.

Read this article if you’d like more information about that opportunity.

Application Deadline: 10th October, 2018

Program Starts: 18th October

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Days
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Hrs
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Start Your Application

Click below to start your journey to a well paid pharma career.

Apply Now

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