This Certificate is Accredited by a World Top 4% University
This Course is Right For You If:
Minimum Entry Requirements:
You must be able to answer “YES” to ALL of the following 4 questions for this “Certificate in Validation”
- Do you have a sound understanding of GMP rules, regulations and guidelines?
- Can you read engineering documentation such as P&IDs and piping isometrics?
- Do you understand IQ, OQ and PQ?
- Can you populate an IQ OQ PQ Validation or Verification protocol used in the BioPharma/Medtech Industry?
NOTE:
If you answer “NO” to any of the 4 questions above, you will first need to take our Equipment Validation Training Course (ONLINE) – For Starter Validation Roles and learn commissioning & qualification of equipment and systems and how to populate an IQ OQ PQ Equipment Validation Protocol. This program covers all the entry requirements above.
What you’ll learn – There are three 10-week modules in this 30-week program
Module 1 – Pharmaceutical Facility Design (Weeks 1-10)
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 underpins 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.
Module 2 – Planning a Validation Strategy (Weeks 11-20)
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 underpins 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.
Module 3 – From URS to PQ – a Validation Project (Weeks 21-30)
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
What Kind of Roles Would I be Suitable For?
The more validation work experience you have, the better positioned you’ll be to successfully apply for more senior roles upon completion of the program. Here are some of the most common job titles we see advertised and the expected salaries.
Validation Technician
Works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result.
Some companies might call this role:
- CQV Specialist
- C&Q Specialist
- Associate QA Validation Specialist
- C&Q Junior Project Manager
- Equipment & Process Validation Specialist
- QA Validation Associate
- QA Validation Specialist
- Validation & Technical Standards Specialist
- Validation Analyst – Qualification section
- Validation Specialist
- Starting Salary: €40,000 to €45,000
- After 2 Years: €45,000 to €60,000
- After 5 Years: €60,000 to €75,000
Validation Engineer
Rigorously test and pre-test the systems used to manufacture products and create and document an evidence trail to show that the systems and equipment used, produce a defect-free consistent result. This is a