1. Planning a Validation Strategy Course
Validation Strategy

Planning a Validation Strategy

Learn how to Develop a Validation Master Plan for the Entire Lifecycle.
  • Generate a Process Validation Protocol
  • Prepare a Summary Validation Report for an Audit
  • Complete Course Online in 10 Weeks
  • Application Deadline: 27th March
Price $2,499

Planning a Validation Strategy

Learn how to Develop a Validation Master Plan for the Entire Lifecycle of Your Product.
Planning a Validation Strategy Course GetReskilled
Pharmaceutical Degree
Pharmaceutical Degree
Pharmaceutical Degree
Pharmaceutical Degree
Pharmaceutical Degree
Pharmaceutical Degree

1 Module over 10 Weeks
Study Online 14 hrs/week 

Join 1223 Learners

27th March
Class Starts: 4th of April

Apply Now

What this Course will Teach You

How do you develop a Validation Master Plan (VMP) for a typical product life cycle? How do you generate a process validation protocol? What is the latest thinking in quality and in validation? Learn all this and more!

Validation Master Plan (VMP)

Learn about what’s new in quality and in validation and develop a Validation Master Plan (VMP) for a typical product life cycle.

Process Validation Protocol

Generate a process validation protocol and execute a process validation study.

Critical Process Parameters

Identify the Critical Process Parameters (CPP’s) and Critical Quality Attributes (CQA’s)

Audit of Suppliers

Complete an audit of suppliers and vendors and their quality plans and documentation.
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What this Course will Teach You

  • Generate a Process Validation Protocol
  • Prepare a Summary Validation Report for an Audit
  • Complete Course Online in 10 Weeks
  • Application Deadline: 9th January

This Course is Right For You If;

  • Need to apply these concepts to work on a daily basis
  • You have direct experience working in an FDA regulated environment
  • You need an Advanced Course that goes deep into this subject
  • You don’t want to waste time or money on hotel or travel fees.

This course is probably not for you, if

  • You have never worked in the pharmaceutical or medical device manufacturing industry.

What Does the Online Classroom Look Like?

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 courses 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 course.
Hear From People Who’ve Taken This Course
Validation Strategy

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 Strategy

Ronan Balfe

“Studying online gives you the time to do the course in your own time yet with assignment deadlines this made you disciplined to meet the deadlines set. I would have no hesitation in recommending these courses to anyone wishing to gain an education in the pharmaceutical sector.”

Validation Strategy

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.”

Your Lecturer

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 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.

Your 10-Week Class Schedule

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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.

Week 1 – What’s new in Validation and in Quality
  • What’s new in Quality and in Validation
  • International Conference on Harmonization (ICH) Overview
  • ICH Q8, Q9, Q10 & Q11
  • Regulatory & Industry Reaction to ICH Guidelines
Week 2 – ISPE Guidance Documents and ASTM E2500
  • ASTM E 2500-07 “Standard Guide for Specification, Design, and Verification of Equipment”
  • ISPE Baseline Guide 5 “Commissioning & Qualification” (2001)
  • ISPE Good Practice Guide “Applied Risk Management for Commissioning & Qualification” (2011)
  • ISPE Guide “Science Risk Based Approach for the Delivery of Systems & Equipment” (2011)
Week 3 – Preparing for Process Validation
  • FDA Guidance for Process Validation (2011)
Week 4 – The Quality Plan, Change Control and the Validation Master Plan (VMP)
  • The Concept of Quality
  • Evolution of Regulations in the EU & US
  • Quality Management Systems
  • The Quality Manual
  • Validation Master Plan
  • Supplier & Vendor Qualification
Week 5 – Process Validation
  • Process Validation – Critical Quality Attributes (CQA’s)
  • Process Validation – Critical Process Parameters (CPP’s)
  • Process Validation Protocol
  • Executing the Process Validation Study4
Week 6 – The Process Validation Report
  • Process Validation Report
  • Preparing for the Regulatory Audit
  • Periodic Review & Continuous Validation
Week 7 – Cleaning Validation
  • Cleaning Validation Strategy
  • Cleaning Validation Report
Week 8 – Health & Safety at the Operator/Product Interface
  • The Operator/Product Interface
  • Health & Safety Regulations
Complete the Following Activities & Workshops

You will produce a number of deliverables during the course including:

  • Risk management during validation planning
  • Auditing suppliers and vendors and their quality plans and documentation
  • Prepare a product validation strategy and plan
  • Prepare a summary validation report
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.

Certified by GetReskilled

You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Dublin Institute of Technology (Ireland) subject to the following criteria;

  • Passing a written or oral Exam on the materials.
  • The submission of all assessments and the end of module assignment.

Join our Alumni who are working for:

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Try Us Risk-FREE for 7 Days 100% Money Back Guarantee.

Application Deadline: 27th March, 2019

Program Starts: 4th April


Start Your Application

Click below to start your application.

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Talk To Our Team

Call Geraldine: +1 (617) 901 9268

Call Sinead: +353 (0)21 2409016

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Frequently Asked Questions

This is an advanced and high level course and is not comparable to a two day course both in the range of content covered and the detail it goes into. Furthermore, spreading the learning over 10 weeks rather than trying to cramp everything into a three day or one week event means that you will dramatically improve your retention of the materials.
This available worldwide and in certain US States. Contact us for details.