Education and Training in Pharma
1. e-Validation (DT 758A)
e-validation

Pharmaceutical Validation Training Course. Retrain for Senior Validation Roles

Want a more interesting job with a higher salary? Our online Validation Program may be the answer. Develop Process Validation Protocols, Plan a Validation Strategy.
  • Advance your career with a higher paying role in validation
  • Turn your work experience into an academically accredited certificate
  • Delivered part-time & online. No needless travel
  • Application Deadline: 21st November
Price $7,499

Pharmaceutical Validation Training Course. Retrain for Senior Validation Roles

Want a more interesting job with a higher salary? Our online Validation Program may be the answer. Develop Process Validation Protocols, Plan a Validation Strategy.
e-Validation Course GetReskilled
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eValidation
eValidation
eValidation
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eValidation

DURATION
3 Module over 30 Weeks
Study Online 14 hrs/week 

APPLY BY
21st November
Class Starts: 29th November

LEVEL
Intermediate – Advanced
Join 3024 Learners

ESTIMATED SALARY
$50k to $98k
Based on US job data

ESTIMATED SALARY
€35k to €85k
Based on Irish job data

Apply NOW & Take the First Steps to Becoming a Validation Professional!

By the end of this program, you will be able to:

Apply NOW & Take the First Steps to Becoming a Validation Professional!

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Program Highlights

  • Advance your career with a higher paying role in validation

  • Acute Shortage of Validation Professionals worldwide
  • Turn your work experience into a University Certification

  • Application Deadline: 21st November

Entry Requirements;

  • You’ve worked in the BioPharma/MedTech manufacturing industry
  • You can populate a Validation (IQ,OQ,PQ) protocol used in the BioPharma/Medtech Industry
  • You can easily read the engineering documentation used to populate a validation protocol such as P&ID’s, piping isometrics and electrical loop drawings.

NEED TO PREPARE? Learn to populate a validation protocol or read engineering documentation with our Commissioning and Qualification of Equipment and Systems Program

This program is for you if;

  • You want to turn your years of work experience in validation into an advanced certification
  • You want to spread your learning over a longer period to suit your personal and business circumstances
  • You don’t want to waste your time, money or training budget on hotel or travel junkets

So What Is Validation?

Validation describes the process of creating an evidence trail to show that an action, process or system leads to a consistent and reproducible result. This ‘result’ is typically either taking a measurement or assessing product quality.

A Validation Engineer is responsible for planning, implementing and monitoring the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.

They measure and analyze the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.

There is currently a high demand for trained validation engineers. As a result, salaries are highly competitive.

Need More Detailed Information?

What is a Validation Engineer?
What is a Validation Technician?
What is a Validation Team Member?
Check out Validation Salaries
Check out his tool on the “Validation Engineers | 5-Mistakes to Avoid on Your First Day”

Watch this Video on a Validation Engineer’s Role!

For a great insight into validation roles from someone actually in the job, check out this video from the About Bioscience website, produced by the North Carolina Association for Biomedical Research (NCABR).

What Kind of Roles Would I be Suitable For?

Depending on your current work experience, here are some of the typical roles you could retrain into and the expected salaries.

Some companies might call this role: Validation Specialist

e-Validation (DT 758A)
  • Starting Salary: €35,000 to €45,000
  • After 2 Years: €40,000 to €55,000
  • After 5 Years: €50,000 to €75,000
e-Validation (DT 758A)
  • Starting Salary: €30,000 to €36,000
  • After 2 Years: €36,000 to €45,000
  • After 5 Years: €45,000 to €50,000

Some companies might call this role: Validation Specialist

e-Validation (DT 758A)
  • Starting Salary: $54,400
  • After 2 Years: $68,000
  • After 5 Years: $81,600
e-Validation (DT 758A)
  • Starting Salary: $40,800
  • After 2 Years: $51,000
  • After 5 Years: $61,200

This Certificate is Accredited by a World Top 2% University

e-validation
  • Largest University in Ireland
  • Named Best Institute of Tehnology by the Sunday Times in 2010
  • Ranked in top 100 by the Times Higher Education for universities under 50 in 2014 and 2015
  • 20,000 registered students
  • Over 2,000 members of staff
  • Member of the European University Association

How Our Online Classroom Works

We designed this Validation training courses for busy professionals who want to fit short chapters of learning into a hectic work and home schedule and cannot afford three, four or five days out of the office.

How-does-Studying-Online-Work

We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
Online programs can start off great, but staying motivated can be a challenge. So, we check your progress weekly to keep you on track and we’ll reach out to you by email or even by phone if you fall behind!
Because it’s online, there are no long commutes, traffic jams or crowded trains to deal with on the way to class. Study at home after the kids have gone to bed.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.

GetReskilled Success Stories

Validation

Sharon Egan

GSK-getreskilled-testimonial-logo

“Structurally Well Planned with the Opportunity for Practical Application”

Like most of us, I had worked on validation projects in the past on a “learn as you go” basis with no formal training in this area. I always felt that there was a knowledge gap so I was both delighted and surprised to discover that GetReskilled were offering the e-Validation course.

I found the course to be interesting, structurally well planned with the opportunity for practical application of the course modules through various assignments.

I have worked in the Medical device/Pharmaceutical and Food industries and found the course to be extremely relevant to all industries.
From URS to PQ, this course provides the relevant learning materials and will help you develop your skills to master validation projects.

Validation

Mehmet Hascan

Johnson&Johnson-getreskilled-testimonial-logo

“Material was Delivered in an Engaging, Interesting and Supportive Way”

Having faced a career change in the middle of an economic downturn, I lost some of myself confidence and needed a major boost. The area of Biopharmaceutical operations and validation was of interest to me as it does play an important role in the pharmaceutical industry at present..

The administration staff and lecturers at Getreskilled/DIT are first class and the course material was delivered in an engaging, interesting and supportive way.

I have now been working at Johnson and Johnson Vision Care as Validation Engineer in Limerick and I look forward to put what I have learned into practice.

Validation

Regina McNamara

Boston-Scientific-getreskilled-testimonial-logo

“I can Study Around Work and Family Commitments”

I decided to take the course with GetReskilled as I wanted to return to work and gain experience. I also made this decision as I like the fact that the Certificate is part of a Degree program. The online experience is working well for me as I study around work and family commitments.

I would recommend this course to anyone that wants to make the transition into the Pharmaceutical and Medical Device Manufacturing industry and is interested in building a successful career in this area.

The companies I applied for were very impressed. It demonstrates that I am a self starter and wished to improve my opportunities in attaining a promotion in the future. I am currently working in Boston Scientific manufacturing Balloon Catheters that are used in Gallstone patients.

Image of previous GetReskilled student Edel Harkins

Edel Harkins

“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”

Image of previous GetReskilled student Ronan Balfe

Ronan Balfe

“I have really enjoyed the course. The course content was very detailed and way surpassed my expectation. While the course was challenging, the online support and access was exceptional. I am really looking forward to progressing to the follow-on/specialization course, “BioValidation” when it becomes available.”

Validation

John Ryan

“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 content 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.”

Pharmaceutical Facility Design

Noel O’Brien

“The quality of the course content was excellent and very substantial and covered all aspects associated within the Pharmaceutical, Bio-Pharmaceutical and Medical Device industries. Information that I feel could and would be very much a requirement for the type of work I would be seeking, within such companies.”

Pharmaceutical Facility Design

Anne Reilly

“Very important to do a course if you have been absent from workplace for a relatively long period. It just gives you the confidence to do interviews etc.”

Pharmaceutical Facility Design

Louise McManus

“Excellent course, well set out.”

Your Lecturers

Our Team

Dr. Joe Brady

Full-time Validation Lead and Lecturer, Dublin Institute of Technology

Dr. Joe Brady is full-time practicing Validation Lead and an assistant lecturer with the Dublin Institute of Technology (DIT), 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 programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.

He is also a supervisor for MSc/MEngSc and Ph.D. theses. Joe has over seventeen years project experience in the pharmaceutical, biopharmaceutical, and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.

about getreskilled

Professor Anne Green

Lecturer, Dublin Institute of Technology

Professor Anne Green is the pharmaceutical technology and pharmaceutical projects manager in Ireland and is a Lecturer in Pharmaceutical Technology, Validation and Pharmaceutical Quality Assurance to undergraduate and postgraduate students at the Dublin Institute of Technology in Ireland.

In addition, she is also secretary of the Parenteral Drug Association (PDA) Secretary, Irish Chapter. Her experience ranges from a technical service chemist, Sterling Wintrop Dungarvan, (now GSK), validation manager at start up Wyeth Newbridge, (now Pfizer) and is a Training Director at NIBIRT in Ireland.

Join our Alumni who are working for:

pfizer company logo
abboutt company logo
novartis company logo
lilly company logo
roche company logo
amgen company logo
sanofi aventis company logo
gsk company logo

Prices & Start Dates

Prices & Start Dates

Prices & Start Dates

Prices & Start Dates

Why not give us a try. Others have and they’ve been impressed!

Application Deadline: 21st November, 2018

Program Starts: 29th November

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Take the First Step

Click below to start your journey to a high paying career in Validation.

Apply NOW & Take the First Steps to Becoming a Validation Professional!

Contact Us

USA/World
Call Geraldine: +1 (617) 901 9268

Ireland
Call Sinead: +353 (0)21 2409016

Your 30-Week Class Schedule

Download Brochure

Your Class Director will check your study logs and only will release subsequent week’s materials to you if you have been logging in for more than 10 hours per week.

And he or she will proactively follow up with you to keep you on track.

Module 1 – Pharmaceutical Facility Design

In this module, you will receive a strong grounding in the modern pharmaceutical 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.

Week 1 – Controlling Air Quality and Clean Utilities Manufacturing Logistics Calculations
Week 2 – Purified Water Generation and Distribution
Week 3 – Clean Steam and Sterilization
Week 4 – Controlling Material and Personnel flows
Week 5 – Aseptic Processing and Vial Filling
Week 6 – Controlling Cleanrooms and Automation
Week 7 – Quality Systems for Cleanrooms
Week 8 – Construction Lifecycle for New and Modified Facilities
Week 9 & 10 – Complete an End of Module Assignment. Develop a site master plan for an aseptic manufacturing process and the design of its environmental control and clean utility systems.

You will complete the following activities and produce a number of deliverables during the program including:

  • Calculating Mass Balances and Equipment Sizing
  • Designing a Clean Utility generation and distribution system
  • Defining the cleanroom layout for safe material and personnel flows
  • Describing the Quality System necessary for manufacturing safe medicines

Module 2 – Planning a Validation Strategy

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.

Week 11 – What’s new in Validation and in Quality
Week 12 – ISPE Guidance Documents and ASTM E2500
Week 13 – Preparing for Process Validation
Week 14 – The Quality Plan, Change Control and the Validation Master Plan (VMP)
Week 15Process Validation
Week 16 – The Process Validation Report
Week 17Cleaning Validation
Week 18 – Health & Safety at the Operator/Product Interface
Week 19 & 20 – Complete an End of Module Assignment. Complete this module with 8 weeks of study and an extra 2 weeks to complete the end of module assignment.

Module 3 – From URS to PQ – a Validation Project 

This is a workshop driven module 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.

Week 21 to 22 – Supplementary Content: Generation of Piping and Instrumentation Diagrams, URS for Hot Detergent and Hot PUW Generation and Distribution Skid System, Equipment List, Instrument List (Incl. both an Attachment and Video Link), Inline Components List (Incl. both an Attachment and Video Link), Piping Line List (Incl. both an Attachment and Video Link), P&ID Instrument Identification (Incl. Video Link Only)
Week 23 – P&IDs
Week 24 – URS Matrix
Week 25 – Workshop
Week 26 – Workshop
Week 27 – Workshop
Week 28 – Workshop
Week 29 – PQ Template
Week 30 – PQ Template

25-Week Advanced Career Coaching Program

You’ll also have access to our Advanced Career Coaching program where many of our trainees have been able to secure employment while still studying. This program walks you through the job hunting process step by step. This is a hands-on program – everything you do within it will advance your job-hunting skills in a very practical way and take you a step closer to landing your ideal job within the pharma or med device industries.

The program covers topics including:

  • How to find the roles that are right for you
  • Assessing your own skill set and how to sell that to employers
  • CV and cover letter writing skills, with personalized feedback
  • How to Network  Effectively
  • How to use social media in your job hunt
  • Interview preparation

During the first 4 weeks, we’ll introduce new skills and lay the groundwork for your job hunt. From week 5 onwards we’ll look to develop those skills and you’ll start applying for jobs.

In addition, you’ll also have access to a program advisor who is there to offer support and guidance, offer personalized feedback and provide additional resources in any areas you need a little extra help.

Meet Claire

Claire runs GetReskilled’s Advanced Career Coaching Program – our specially devised job hunting program that will help you find a job.

e(Bio) PharmaChem (DT 698)

Academically Accredited by DIT

This CPD Certificate (Continuous Professional Development) is academically accredited by the Dublin Institute of Technology (DIT), Ireland subject to the submission of all assessments and end of module assignments.

  • CPD: Level 7
  • Program Credits (ECTS): 15
  • Awarding Body: DIT

Admission Criteria

People with a technical, production, science, logistics or quality background who want to make a career change into the pharmaceutical, bio pharmaceutical and medical device industries or those already working in these sectors.

Recognized prior learning (RPL) will be taken into account in assessing applicants for this program.

Available Worldwide

This e-Validation program is available worldwide.

Frequently Asked Questions

  • Will I be ready to apply for a more senior validation role? Yes
  • Is this course delivered online? Yes
  • Are all course materials available 24/7? Yes
  • Can I take this program at an accelerated pace and finish it sooner than 30 weeks? Yes it's possible, talk to us for details.
  • Do I need to be online all the time? No you don't
  • I live in the UK/Europe/USA/Australia etc,. Can I still take this program? Yes
  • Can I have my employer pay for this? Yes
  • Can I spread the payments over a couple of months? Yes
  • Will I have my own personal course leader who protactively follows up with me to make sure I get to the end of the course. Yes
  • Will you guarantee me a job in Validation at the end? No, but we can guarantee that salaries in the Pharma/MedTech sector are 30% above average.

Take the First Step

Click below to start your journey to a high paying career in Validation.

Apply NOW & Take the First Steps to Becoming a Validation Professional!

Talk To Our Team

USA/World
Call Geraldine: +1 (617) 901 9268

Ireland
Call Sinead: +353 (0)21 2409016

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