Validation Strategy

Process Validation Training (Online) 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 4th November

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

LEVEL
Intermediate
Join 1223 Learners

APPLY BY
Wednesday 4th Nov
Class Starts: 12th Nov

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.

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.
We release only one week’s worth of material at a time and then MANUALLY check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. And you’ll have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind.
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

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

Dr.Joe Brady Lecturer at GetTeskilled

Dr. Joe Brady

Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled

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 PhD theses. Joe has over twenty years of 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

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

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You can add your education, certificates and everything you learned and earned at GetReskilled into the Education section of your profile.

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Syllabus   Faq   Price

Frequently Asked Questions

Yes, this program is delivered fully online so you can learn from home (or anywhere). Study after the kids have gone to bed.

Each week or session of online content typically includes 6-10 topics. Each topic includes:

  • A set of course notes – these provide additional depth to the video content.
  • Warm-up self-assessment question – to recap or activate any relevant prior learning.
  • A video – these are typically 5-10 minutes long and deliver 80% of the course content.
  • Post video self-assessment questions to check how well you can recall this new material from memory.
  • Any follow up assessments or assignments.

We release only one week’s worth of material at a time and then check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. There is a “Progress Bar “on your course which is helpful to you and us to know how you are doing.

You have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind. She’ll also be in touch weekly to let you know when new content is open for you.

Yes, you can speed up or slow down the rate of delivery to suit your requirements. The most important thing is communication between you and your course coordinator.

If you are taking a break or are busy at work and do not have time to study you need to tell her or him. Similarly, if you want to study at a faster rate, then just email in good time and ask for more course content.

No you don’t. The online classroom is open 24 hours a day so you do not have to login at any particular time. We will give you a Username and Password on the day the program starts and this allows you 24 hours a day access.

Yes, a number of our students have their employers pay for this program.

Application Deadline: Wednesday 4th November 2020

Program Starts: 12th November

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Start Your Application

Click below to start your application.

Apply Now and Learn to Develop Process Validation Protocols

Talk To Our Team

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

Ireland
Call Sinead: +353 (0)21 2409016

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