Specialise in Validation

Take this “Certificate in eValidation” & Become a Validation Professional.

  • Acute shortage of  Validation Professionals worldwide
  • 30 week academically accredited course
  • High paying jobs (30% above average)
Validation

Intermediate

Join 3,024 Learners Worldwide

Online, 30 weeks, 14 hrs / week

Build on your work experience and previous qualifications and move into to the Highly Paid Role of Validation Specialist in the Pharma or Med Device Manufacturing Industry.

Learn to Write a Validation Plan

Add to your existing skill sets and learn how to write a Validation Master Plan. Prepare a process validation protocol and develop performance qualification test scripts based on the key process measurements of a URS (User Requirement Specification).

Clean Air and Purified Water Systems

Learn how clean air and purified water systems and delivered in regulated manufacturing environment, so as to ensure that these critical systems are fit-for-purpose.

Complete 3 Academically Accredited Modules

Complete 3 modules; Pharmaceutical Facility Design (VOMP 3006), Planning a Validation Strategy (VOMP 3008) and From URS to PQ – a Practical Validation Project.

Give Yourself a Competitive Edge

Compile a portfolio of projects and assignments for yourself to give you a competitive edge when applying for positions within Validation Teams.

All Pharmaceutical Degree & Certificate Programs are Academically
Accredited by the Dublin Institute of Technology, Ireland

e(Bio) PharmaChem

Career Opportunities

What kind of roles could I apply for after finishing this course?

Background
RolesAverage US Salaries: Source BLS
Pharmaceutical Industry Experience?
Apply for these Validation Roles >>
Quality Coordinator
Validation Engineer
Quality Engineer
Document Management Specialist
$ 48,000
$ 90,000
$ 86,000
$ 47,500
Add Computer Systems Validation Course
to Apply for these Automation Roles >>
Automation Engineer
Systems Engineer
Applications Engineer
Computer Operations Specialist
$ 96,350
$ 110,650
$ 85,000
$ 87,500

Work Background and Age Profile of Students on this Course

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Online Learning Done Differently

or: Why this is an Online Course You’ll Actually Finish!

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
Online courses can start off great, but staying motivated can be a challenge. So, you’ll get regular feedback reports (and emails or phone calls if you fall behind!) to keep you on track.
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 course.
Companies who’ve hired our alumni
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Companies who’ve hired our alumni
GetReskilled Success Stories
Validation

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!”

Validation

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.”

Andy Wnuk, MSc (Eng) MIEI

“Along with the technical training in I would rate the course 10 out 10 and would highly recommend to others, very interesting, informative and very well presented. Relevant totally to my needs and expectations.”

David O’Shea, March 2012

“I found this course very beneficial and I am delighted that, even at early stages in the course, it has already provided me with the opportunity to secure a position within the pharmaceutical industry.”

Denis Hegarty, May 2012

“I found the course was run very professionally, The course notes and videos supplied were excellent, the notes tied in very efficiently and accurately with the videos. Dr Joe Brady’s presentation on the videos and his expertise and help at the webinars was outstanding. I found it very easy to continue studying even though I found employment two months into the course. I would highly recommend this course to anyone hoping to further their education in this field.”

Tan Sear Enyu, Venture Corporation Limited, SA

“The lecturers have vast knowledge to share and are technical specialists within the Life Sciences Industry…there was a lot of encouragement and team exchange of experience to bring in for class work and assignment participation.”

Lecturer

Our Team

Dr. Joe Brady

Lecturer, Dublin Institute of Technology

Dr. Joe Brady is 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 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 seventeen years project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.

about getreskilled

Dr. Anne Green

Lecturer, Dublin Institute of Technology

Dr 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.

Prices & Start Dates

Please Note: There is an acute shortage of people with Validation Skills especially in the Republic of Ireland which has experienced a huge resurgence in construction in the last two years.

Prices & Start Dates

Please Note: There is an acute shortage of people with Validation Skills especially in the Republic of Ireland which has experienced a huge resurgence in construction in the last two years.

Prices & Start Dates

Please Note: There is an acute shortage of people with Validation Skills especially in the Republic of Ireland which has experienced a huge resurgence in construction in the last two years.

Syllabus

Complete 3 Modules over 30 Weeks

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 underpin 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 course 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 15 – Process Validation
Week 16 – The Process Validation Report
Week 17 – Cleaning 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

Career Coaching

Your Job Hunt is the most important part of your transition into the industry, and we are here to help. In a series of 10 recorded workshops, we de-mystify the job hunting process. The course is written by recruiters and, therefore, it is all about getting you into the mindset of those who will be hiring you and includes areas such as;

  • Write an Effective CV
  • How to  Interview Effectively
  • How to  Research the Job Market
  • How to Network  Effectively
  • How to use LinkedIn for your Job Hunt

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
  • Programme 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 course is available worldwide and in certain US states.

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Frequently Asked Questions

The majority of the people are in their 30’s and 40’s with some in their 20’s and 50’s.
Ideally, you should have at least 5 years relevant work experience or a technical qualification in science or engineering and a minimum of a second level qualification (High School Diploma, Leaving Certificate, A or O Levels, etc).

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Is a Pharma Career for Me?

What Courses Should I Take?

These are conversion courses to help people leverage off their qualifications and work experience to move into a career in pharmaceutical and medical device manufacturing. They are not for fresh graduates.

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