online pharmaceutical validation training course

University Accredited by TU Dublin at Level 7

Pharmaceutical Validation Training Course (ONLINE). For Senior Validation Roles

University Accredited

Pharmaceutical Validation Training Course (ONLINE)  – For Senior Validation Roles

Want a more interesting job with a higher salary? Our level 7 Certificate in Validation Training Program may be the answer. Develop Process Validation Protocols, Plan a Validation Strategy.
  • Turn your practical work experience into an university accredited certificate
  • Get a more interesting job with a higher salary
  • Application Deadline: Wednesday 7th October

Universtiy Accredited by TU Dublin at Level 7

Pharmaceutical Validation Training Course (Online) – For Senior Validation Roles

University Accredited

Pharmaceutical Validation Training Course (Online) – For Senior Validation Roles

Want a more interesting job with a higher salary? Our level 7 Certificate in Validation Training Program may be the answer. Develop Process Validation Protocols, Plan a Validation Strategy.
online pharmaceutical validation training course

Our learners work at industry-leading companies such as:

Pfizer Logo

Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

Novartis Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

JNJ Logo

ESTIMATED SALARY
$50k to $98k
Based on US job data

ESTIMATED SALARY
€35k to €85k
Based on Irish job data

DURATION
3 Module over 30 Weeks
Study Online 14 hrs/week 

LEVEL
Intermediate – Advanced
Join 3024 Learners

APPLY BY
Wednesday 7th Oct
Class Starts: 15th Oct

Apply NOW & Retrain for Senior Validation Roles

This Program is Right For You If;

  • You want to turn your years of work experience into a University Certification.

  • Your work in Quality Assurance but have to sign off on validation documents you don’t fully understand!

  • You want to spread your learning over a longer period to suit your personal and business circumstances.

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

And..

  • It delivered Part-Time online so you can learn from home (or anywhere). Study after the kids have gone to bed.

By the end of this program, you will be able to:

Apply NOW & Retrain for Senior Validation Roles

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This Course is Right For You If;

  • You want to turn your practical work experience into a University Certification.

  • You want more Senior Validation Roles and higher pay.

  • Your work in Quality Assurance but have to sign off on validation documents you don’t fully understand!

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

  • Delivered Part-Time online so you can learn from home (or anywhere). Study after the kids have gone to bed.

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

Join our students who work at industry-leading companies such as:

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

Minimum Entry Requirements;

You must be able to answer “YES” to ALL of the following for this Senior Validation Course

  • 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 Online Starter Validation Course and learn commissioning & qualification of equipment and systems and how to populate an IQ OQ PQ Validation Protocol. This program covers all the entry requirements above.

Ideal for:

  • Pipefitters / plumbers / pipe welders / electricians / instrument or boiler technicians (i.e. those that can interpret technical drawings)
    Or
  • Those with Commissioning & Qualification experience in ANY industry
    Or
  • Those with GMP manufacturing experience

…who want: a starter-level validation role in pharmaceutical manufacturing

So What Is Validation?

Validation describes the process of creating an evidence trail to show that an action, process or system leads to a consistent and reproducible result. This ‘result’ is typically either taking a measurement or assessing product quality.

A Validation Engineer is responsible for planning, implementing and monitoring the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.

They measure and analyze the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.

There is currently a high demand for trained validation engineers. As a result, salaries are highly competitive.

Need More Detailed Information?

What is a Validation Engineer?
What is a Validation Technician?
Check out Validation Salaries
Check out his tool on the “Validation Engineers | 5-Mistakes to Avoid on Your First Day”

What Kind of Roles Would I be Suitable For?

Depending on your current work experience, here are some of the typical roles you could retrain into and the expected salaries.

Some companies might call this role: CQV Engineer, C&Q Specialist, Validation Specialist

validation engineer certification
  • Starting Salary: €35,000 to €45,000
  • After 2 Years: €40,000 to €55,000
  • After 5 Years: €50,000 to €75,000
validation engineer training
  • Starting Salary: €30,000 to €36,000
  • After 2 Years: €36,000 to €45,000
  • After 5 Years: €45,000 to €50,000

Some companies might call this role: CQV Engineer, C&Q Specialist, Validation Specialist

e-Validation (DT 758A)
  • Starting Salary: $54,400
  • After 2 Years: $68,000
  • After 5 Years: $81,600
e-Validation (DT 758A)
  • Starting Salary: $40,800
  • After 2 Years: $51,000
  • After 5 Years: $61,200

Your 30-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

Module 1 – Pharmaceutical Facility Design

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.

  • Manufacturing Logistics Calculations
  • Process Flow Diagram (PFD)
  • Controlling Air Quality
  • Heating, Ventilation, and Air Conditioning (HVAC) Systems
  • Biopharmaceutical Unit Operations – Drug Substance / Drug Product • Pharmacopeia Grade Waters
  • Process Support and Utilities
  • ISO 9001:2008
  • Typical GMP list for drug substance
  • Operational Activities
  • GMP for Personnel
  • Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Model
  • Maintenance: Good and Best Practices
  • Project Lifecycle for New and Modified Facilities
  • IPlant Layout
  • Layout For Bulk Process Building
  • Site Layout
  • IZoned Air Conditioning System
  • Isolator technology
  • IIsolators and RABs
  • Cell Breakage
  • IPurified Water
  • Purified Water Generation
  • IPurified Water Storage and Distribution
  • Clean Room and Clean Air Device Monitoring
  • Good Engineering Practices Procedures
  • GMPs for Buildings and Facilities
  • Maintenance Program
  • Conceptual Design – Part-I
  • HAVC Requirements for Non Sterile API Manufacturi
  • Plant Automation
  • Plant Steam
  • Clean Steam Generators
  • Clean Steam Generators 2
  • Steam Sterilization-In-Place
  • GMPs for Process Equipment
  • Quality Systems Approach to Pharmaceutical cGMP Regulations – Resources
  • Conceptual Design – Part-II
  • Air Flow Patterns
  • Air Flow Patterns Laminar Flow Systems
  • Cleanroom Layout General Introduction
  • Cleanroom Layout HVAC Containment (non-sterile API manufacturing)
  • Filter Ratings – European Standards
  • Filter Ratings – MERV Rating
  • Logic Gates Functions, and Programmable Logic Controller (PLC)
  • Water for Injection (WFI) Storage and Distribution
  • Principles of Good Engineering Practices (GEP)
  • Quality Systems Approach to Pharmaceutical cGMP Regulations – Manufacturing
  • Maintenance Work Execution
  • Site Master Planning – Part-I
  • Classification of Clean Areas – Vial Filling
  • Classification of Clean Areas – Cleanroom HVAC Configurations
  • Classification of Clean Areas – AHU
  • Classification of Clean Areas – Particles
  • Classification of Clean Areas – CFU
  • Area Classification Protection
  • Compressed Air, and Pneumatics
  • Aseptic Filling – Sterile Medicinal Containers
  • Aseptic Filling – Vial Inspection
  • Aseptic Filling – Vial Washing
  • Aseptic Filling – Vial Depyrogenation
  • Aseptic Filling – Vial Filling
  • Cleanroom Gowning
  • Aseptic Processing – Automated Loading System
  • Aseptic Processing – Manual Loading System
  • Aseptic Processing – Automated Barrier Systems
  • Cleanroom Monitoring – Physical Tests
  • Quality System – Evaluation Activities
  • Maintenance Management
  • Site Master Planning – Part-II
  • Open versus Closed Processing
  • Facility Layout Concept
  • Blow/fill/seal technology
  • PLC Programming
  • PLC Program Case Studies
  • Cleanroom Monitoring – Microbiological Tests
  • Cleanroom Monitoring – Cleanrooms Cleaning Procedures
  • Terminally sterilised products
  • EU Guidelines on Clean Room Aseptic preparation
  • HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing
  • Batch Process Control
  • Nitrogen Supply and Distribution
  • Environmental Monitoring Program
  • ICH Q10 – Pharmaceutical Quality System
  • FDA Guidance on Aseptic Processing
  • Construction Lifecycle – New and Modified Facilities
  • Construction Lifecycle – Test Packs
  • Construction Lifecycle – Modular and Sustainability
  • Software Functional Block Diagram (FBD)
  • ASTM E 250

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

  • Calculating Mass Balances and Equipment Sizing
  • Designing a Clean Utility generation and distribution system
  • Defining the cleanroom layout for safe material and personnel flows
  • Describing the Quality System necessary for manufacturing safe medicines
Develop a site master plan for an aseptic manufacturing process and the design of its environmental control and clean utility systems.

Module 2 – Planning a Validation Strategy

This module will give you a broad understanding of how to develop a Validation Master Plan (VMP) for a typical product lifecycle and to prepare the Process Validation Protocol for presentation during a regulatory audit.

  • 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

Complete this module with 8 weeks of study and an extra 2 weeks to complete the end of module assignment.

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

Module 3 – From URS to PQ – a Validation Project 

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.

Week 21 to 22 – Supplementary Content: Generation of Piping and Instrumentation Diagrams, URS for Hot Detergent and Hot PUW Generation and Distribution Skid System, Equipment List, Instrument List (Incl. both an Attachment and Video Link), Inline Components List (Incl. both an Attachment and Video Link), Piping Line List (Incl. both an Attachment and Video Link), P&ID Instrument Identification (Incl. Video Link Only)
Week 23 – P&IDs
Week 24 – URS Matrix
Week 25 – Workshop
Week 26 – Workshop
Week 27 – Workshop
Week 28 – Workshop
Week 29 – PQ Template
Week 30 – PQ Template

Academically Accredited by Technological University Dublin (TU Dublin)

This CPD Certificate (Continuous Professional Development) is academically accredited by Technological University Dublin (TU Dublin), Ireland subject to the submission of all assessments and end of module assignments.

  • Level 7
  • Program Credits (ECTS): 15
  • Awarding Body: TU Dublin

Available Worldwide

This Pharmaceutical Validation Training Course (Certificate in eValidation) is available worldwide.

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