Validation Strategy

Process Validation Training Course for the Pharmaceutical Industry

How do you generate a process validation protocol? How do you develop a Validation Master Plan (VMP) for a typical product life cycle? What is the latest thinking in quality and in validation? Take this ONLINE Course and quickly get up to speed.
  • Generate a Process Validation Protocol
  • Prepare a Summary Validation Report for an Audit
  • Complete Course Online in 10 Weeks
  • Application Deadline: Wednesday 20th November
Price $2,499

Process Validation Training Course for the Pharmaceutical Industry

How do you generate a process validation protocol? How do you develop a Validation Master Plan (VMP) for a typical product life cycle? What is the latest thinking in quality and in validation? Take this ONLINE Course and quickly get up to speed.
Planning a Validation Strategy Course GetReskilled

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DURATION
1 Module over 10 Weeks
Study Online 14 hrs/week 

LEVEL
Intermediate
Join 1223 Learners

APPLY BY
Wednesday 20th November
Class Starts: 28th November

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Apply Now and Learn to Populate Process Validation Protocols

This Program is for you if;

  • You need to generate process validation protocols and prepare a summary validation report for an audit.
  • You need an Advanced Course that goes deep into validation strategy.

  • You don’t want to waste your time, money or training budget on hotel or travel junkets.

  • You want end-of-week progress checks and follow by us to MAKE SURE you finish the course.

  • Delivered Online you can work full time and still study without wasting your time or money commuting or getting stuck in traffic.

Apply Now and Learn to Develop Process Validation Protocols

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This Course is for you if;

  • You need to generate process validation protocols and prepare a summary validation report for an audit.
  • You need an Advanced Course that goes deep into validation strategy.

  • You don’t want to waste your time, money or training budget on hotel or travel junkets.

  • You want end-of-week progress checks and follow by us to MAKE SURE you finish the course.

  • Delivered Online you can work full time and still study without wasting your time or money commuting or getting stuck in traffic.

About   Syllabus   Faq   Price   Apply

Entry Requirements

  • You have worked in a GMP Regulated Pharmaceutical or Medical Device manufacturing environment.
  • You have a solid understanding of the fundamentals of qualification and validation.

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

John Ryan

“The course content material is concise and interesting”

“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.”

Validation Strategy

Ronan Balfe

“I would have no hesitation in recommending these courses”

“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

Edel Harkins

“Highly recommended to anyone who has been out of the industry for a period of time”

“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!”

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.”

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Delivered by an Industry Expert

Our Team

Dr. Joe Brady

Full-Time Validation Lead and Lecturer, Technological University Dublin

Dr. Joe Brady is 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 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.

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Your 10-Week Class Schedule

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.

Download Brochure
  • 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
  • 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)
  • FDA Guidance for Process Validation (2011)
  • The Concept of Quality
  • Evolution of Regulations in the EU & US
  • Quality Management Systems
  • The Quality Manual
  • Validation Master Plan
  • Supplier & Vendor Qualification
  • Process Validation – Critical Quality Attributes (CQA’s)
  • Process Validation – Critical Process Parameters (CPP’s)
  • Process Validation Protocol
  • Executing the Process Validation Study4
  • Process Validation Report
  • Preparing for the Regulatory Audit
  • Periodic Review & Continuous Validation
  • Cleaning Validation Strategy
  • Cleaning Validation Report
  • The Operator/Product Interface
  • Health & Safety Regulations
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 this module with 8 weeks of study and an extra 2 weeks to complete the end of module assignment.
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.

Show Off Your New Skills: Get a Planning a Validation Strategy Certificate of Completion

Once the course is over, complete a written assignment to get certified in Planning a Validation Strategy.

Add it to your resume, your LinkedIn profile or just get that well-earned raise you’ve been waiting for.

Planning a Validation Strategy Course

Join our Students who are working for:

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

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GSK Logo

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Frequently Asked Questions

  • Is this course delivered online? Yes
  • I have never worked in the Pharmaceutical or Medical Manufacturing Industry before. Can I take this program? Yes, talk to our team
  • Can I pause the class if I get to busy at work or because of family commitments? Yes
  • Are all course materials available 24/7? Yes
  • Can I take this program at my own pace? Yes
  • 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 coordinator who follows up with me to make sure I get to the end of the course. Yes
  • Will I have access to the materials after the course is finished? Yes for 6 months.

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