Planning a Validation Strategy

Learn how to develop a validation master plan for the entire life cycle of your product

  • Generate a process validation protocol
  • Prepare a summary validation report for an audit
  • Complete course online in 10 weeks

Intermediate

Join 3,102 Learners Worldwide

Online, 10 weeks, 14 hrs / week

Price   |   Syllabus

Learn how to Develop a Validation Master Plan

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

Learn about what’s new in quality and in validation and develop a Validation Master Plan (VMP) for a typical product life cycle.
Generate a process validation protocol and execute a process validation study.
Generate a process validation protocol and execute a process validation study.
Identify the Critical Process Parameters (CPP’s) and Critical Quality Attributes (CQA’s)
Complete an audit of suppliers and vendors and their quality plans and documentation.
Prepare a product validation strategy and conduct risk management during validation planning.

Watch Video

Watch a sample video from the course on IQ/OQ/PQ and Process Validation

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.
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GetReskilled Success Stories
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.”

Lecturer

Joe Brady
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.

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Price

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

Syllabus

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.

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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.

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