Pharmaceutical Validation Training Course (ONLINE) – For More Senior Validation, CQV and C&Q Roles

Want a more senior validation engineer, CQV or C&Q job with a higher salary? Take our NFQ level 7 University Certificate in Validation Training Course. Develop process validation protocols. Plan a validation strategy. Develop a validation master plan for the lifecycle of a product. Get a competitive edge when applying for jobs. Developed in consultation with the pharma industry including Pfizer and MSD. University Accredited by TU Dublin Ireland.

Turn your validation work experience into a TU Dublin university certificate.
Get a more interesting job with a higher salary. Charge higher hourly rates.
Estimated salaries $55,000 – $109,000 plus overtime, bonuses and allowances. (Based on the United States Bureau of Labor Statistics (BLS) data)
Application Deadline: Wednesday 18th December

Turn your validation work experience into a TU Dublin university certificate.
Get a more interesting job with a higher salary. Charge higher hourly rates.
Estimated salaries €45,000 – €100,000 plus overtime, bonuses and allowances. (Based on Irish job data)
Irish NFQ: Level 7
Application Deadline: Wednesday 18th December

Study Part-Time Online
Course materials are available 24/7. There are NO ZOOM classes!
3 Modules over 30 Weeks
Join 1330 Learners

NOTE: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course.

UNIVERSITY ACCREDITED

Apply NOW & retrain more senior validation, CQV or C&Q roles →

University Accredited by TU Dublin Ireland

Contact Details For This Course

Geraldine Creaner

+353 (0)21 240 9016

+1 (617) 901 9268

+44 078 0237 0554

This Certificate is Accredited by a World Top 4% University

Technological University Dublin (TU Dublin) is one of the largest universities in Ireland
Named Best Institute of Technology by the Sunday Times in 2010
Ranked in the top 100 by the Times Higher Education for universities under 50 in 2014 and 2015
30,000 registered students
Over 2,000 members of staff

View Course Price →

Pharmaceutical Validation Training Course (ONLINE) – For More Senior Validation, CQV and C&Q Roles

UNIVERSITY ACCREDITED

Turn your validation work experience into a TU Dublin university certificate.
Get a more interesting job with a higher salary. Charge higher hourly rates
Estimated salaries $55,000 – $109,000 plus overtime, bonuses and allowances. (Based on the United States Bureau of Labor Statistics (BLS) data)
Application Deadline: Wednesday 18th December

Turn your validation work experience into a TU Dublin university certificate.
Get a more interesting job with a higher salary. Charge higher hourly rates
Estimated salaries €41,000 – €100,000 plus overtime, bonuses and allowances. (Based on Irish job data)
Irish NFQ: Level 7
Application Deadline: Wednesday 18th December

Study Part-Time Online
Course materials are available 24/7. There are NO ZOOM classes!
3 Modules over 30 Weeks
Join 1330 Learners

NOTE: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course.

This Certificate is Accredited by a World Top 4% University

Technological University Dublin (TU Dublin) is one of the largest universities in Ireland
Named Best Institute of Technology by the Sunday Times in 2010
Ranked in the top 100 by the Times Higher Education for universities under 50 in 2014 and 2015
30,000 registered students
Over 3,000 members of staff

See Course Price →

Apply NOW & retrain more senior validation, CQV or C&Q roles →

University Accredited by TU Dublin Ireland

Contact Details For This Course

Geraldine Creaner

+353 (0)21 240 9016

+1 (617) 901 9268

+44 078 0237 0554

Our learners work for the world’s biggest pharma and medical device companies

Our graduates work for the world’s biggest pharma and medical device companies

This course is right for you if:

You want to turn your validation work experience into a University Certification and charge higher hourly rates.
You want more Senior Validation Engineer, Technician, CQV or C&Q roles and higher pay.
Your work in Quality Assurance/Quality Control 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.

Develop Process Validation Protocols

For a validated process to meet the requirements of a regulatory audit.

Plan a Validation Strategy

From the development of a validation master plan for the entire lifecycle of a product.

Develop an Industry Portfolio

Give yourself a competitive edge when applying for jobs.

Join a Validation Team

You’ll have working knowledge of the everyday activities of a Validation Team.

TU Dublin’s Minimum Entry Requirements:

You must be able to answer “YES” to ALL of the following 4 questions for this “Certificate in eValidation”

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 Equipment Qualification 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 Qualification Protocol. This program covers all the entry requirements above.

See Course Price →

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 more senior role.

Some companies might call this role:

CQV Engineer
Manager / Associate Manager – QA Validation
Mgr/ Snr Mgr QA Validation Oversight
QA Validation Engineer
Quality & Validation Engineer
Senior Validation Engineer
Senior Validation Specialist
Staff Engineer, Quality/Validation
Validation Scientist

Starting Salary: €39,000 to €50,000
After 2 Years: €45,000 to €60,000
After 5 Years: €60,000 to €100,000

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: $40,800
After 2 Years: $51,000
After 5 Years: $65,200

Validation Engineer

Some companies might call this role:

CQV Engineer
Manager / Associate Manager – QA Validation
Mgr/ Snr Mgr QA Validation Oversight
QA Validation Engineer
Quality & Validation Engineer
Senior Validation Engineer
Senior Validation Specialist
Staff Engineer, Quality/Validation
Validation Scientist

Starting Salary: $54,400
After 2 Years: $68,000
After 5 Years: $90,000+

Process Validation Engineer

This is generally considered an advanced role and requires thorough process knowledge and experience with process validation engineers working in engineering design, tech-transfer, upstream and downstream manufacturing. Most practitioners tend to have a lab/science, chemistry or chemical/process engineering background although or have learnt experientially on the job through extensive work experience.

Cleaning Validation Engineer

Design and develop cleaning procedures for new products and manufacturing equipment and also investigate and conduct troubleshooting/root cause analysis of cleaning-related incidents, and deviations for non-validated or underdeveloped cleaning procedures. This is a highly specialised role requiring in-depth knowledge of chemical cleaning processes so most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience or on-the-job training.

Some companies might call this role:

Cleaning Validation Specialist
QA Validation Specialist – Cleaning Validation
QA Validation – Clean Hold Executor

Your 30-week class schedule

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.

Week 1 – Controlling Air Quality and Clean Utilities Part 1

1.1 Manufacturing Logistics Calculations
In this lesson, we learn how to determine the size and capacity of primary processing equipment based on patient dosage requirements and the number of potential patients.
1.2 Process Flow Diagram (PFD)
1.3 Controlling Air Quality In this lesson, we take our first look at an air handling unit (AHU) and describe its functions.
1.4 Heating, Ventilation, and Air Conditioning (HVAC) Systems In this lesson, we take a look at an overall heating and ventilation control (HVAC) system and explain its primary attributes.
1.5 Basic Biopharmaceutical Unit Operations
1-5-1 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug substance manufacturing operation.
1-5-2 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug product formulation/fill-finish and packaging/labelling manufacturing operation.
1.6 Pharmacopeia Grade Waters
1.7 Process Support and Utilities
In this lesson, we take a look at the clean utilities requirements for a biopharmaceutical drug substance manufacturing process.

Week 2 - Controlling Air Quality and Clean Utilities Part 2

2.1 Introduction to ISO 9001:2008 and ISO9001:2015
This lesson is about the key requirements of a quality management system.
2.2 Typical GMP list for drug substance
This lesson explores the content of ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”.
2.3 Operational Activities
In this lesson, we take a look at how to maintain a critical computerized system in a state of operational control using standard procedures.
2.4 GMP for Personnel
2.5 Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Mode
In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations and evaluation activities.
2.6 Maintenance: Good and Best Practices
In this lesson, we describe basic and good practices associated with maintenance in a regulated environment.

Week 3 – Purified Water Generation and Distribution Part 1

3.1 Project Lifecycle for New and Modified Facilities
In this lesson, we describe the typical phases of a project lifecycle: conceptual design, tender contract analysis, basic engineering, detailed design, and project realization.
3.2 Plant Layout
In this lesson, we explore the vertical distribution of process equipment for a bulk process building, the horizontal layout for a bulk process building, and an entire site layout for an integrated biopharmaceutical manufacturing site.
3.3 Zoned Air-Conditioning Systems
In this lesson, we look at a practical example where a HVAC system can be dynamically operated to control the temperature of a room (space
3.4 Isolator Technology
In this lesson, we explain the principles behind the use of ‘isolators’ and Restricted Access Barrier Systems (RABs) for critical ‘open processing’ operation.
3.5 Cell Breakage
In this lesson, we describe a mechanism for bacterial cell disruption for the recovery of intracellular products.

Week 4 – Purified Water Generation and Distribution Part 2

4.1 Purified Water (PUW) Generation, Storage and Distribution
In these lessons, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
4.2 Clean Room and Clean Air Device monitoring
4.3 Good Engineering Practices Procedures
In this lesson, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
4.4 GMPs for Buildings and Facilities
4.5 Quality Systems Approach to cGMP Regulations – Management Responsibilities
In this lesson, we outline management’s role in the design, implementation, and management of the quality system.
4.6 Maintenance Program
In this lesson, we describe the key aspects of a typical maintenance program.

Week 5 – Clean Steam and Sterilization

5.1 Conceptual Design – Part-1
In this lesson, we begin to explore a quantified effort in how to size, shape, program, and cost an investment.
5.2 HVAC Requirements for Non-Sterile API Manufacturing
In this lesson, we look at how to use airflow direction as a means of a containment barrier between operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
5.3 Plant Automation
This lesson is an introduction to conventional process control using one-way digital and analogue signals.
5.4 Plant Steam
In this lesson, we describe a process for generating and distributing plant steam to various processes within a manufacturing facility, and also describe how to manage any resultant condensate.
5.5 Clean Steam Generators
The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation.
5.6 Steam Sterilization in Place
In these lessons, we look at the mechanism behind sterilization of process equipment using saturated steam.
5.7 GMPs for Process Equipment
5.8 Quality Systems – Resources
In this lesson, we describe what resources need to be allocated for a quality system and operational activities.

Week 6 – Controlling Material and Personnel Flows

6.1 Conceptual Design – Part-2
This lesson describes what influences the layout of a facility in terms of: Layers, Preliminary Layout, Process Layouts, Media and Buffer Preparation, Clean Utilities and CIP, Access Corridors, Warehouse / Material Movements, Personnel Movements, Decisions on Height, Air Handling, General Utilities, Electrical, Controls & Automation, Finishes, Structural / Civil, Cost Estimate, and Schedule.
6.2 Air Flow Patterns
In these lessons, we look at laminar air-flow patterns in the context of filling open vessels aseptically, and at the configuration and operation of both a laminar flow booth and a laminar flow cabinet typically found in the biopharmaceutical industry.
6.3 Cleanroom Layout
In this lesson, we take a high-level look at a common cleanroom configuration and discuss items such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
6.4 Filter Ratings
In these lessons, we look at the particle retention efficiencies of air filters of various grades rated in accordance with European normalisation standards EN779 and EN1822. We also look at the particle arrestance efficiency of air filters of various grades rated in accordance with the ASHRAE standard 52-2 ‘Minimum Efficiency Reporting Value (MERV Rating)’.
6.5 Logic Gates Functions and PLC
6.6 WFI Storage and Distribution
In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification.
6.7 Good Engineering Practices Procedures
6.8 Quality systems Approach- Manufacturing
In this lesson we describe Manufacturing’s responsibilities for (a) designing, developing, and documenting product and processes, (b) examining inputs, (c) performing and monitoring operations, and (d) addressing nonconformities.
6.9 Maintenance- Work Executions
In this lesson we describe the following Maintenance tasks and activities: (a) work request, (b) work order management, (c) information requirements for work orders, and (d) performance measurement.

Week 7 – Aseptic Processing and Vial Filling

7.1 Site Master Planning – Part-I
In this lesson, we take our first look at site master planning based on: planning rationale, assumptions, prerequisites, typical bulk production unit, site scope, flexibility, expandability, & future-proofing, determining size requirements, sizing & shaping, and broad rules.
7.2 Classification of Clean Areas – Vial Filling
In these lessons, we look at: (1) how to classify areas for aseptic operations, (2) typical configurations of air handling units (AHU’s), terminal filters, zone air-inlets and -exhausts to support various classified environments, (3) filter arrangements in air handling units and in their supply air ducting, (4) particles limits associated with various classified air environments, and (5) viable microbial limits, measured as Colony Forming Units (CFU), associated with various classified air environments.
7.3 Area Classification Protection
In this lesson, we observe a range of airlock configurations typically used in combination under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient.
7.4 Compress Air and Pneumatics
7.5 Aseptic Filling
In this lesson, we describe the process equipment for the filling of medicinal vials aseptically in the sequence of: washing, dehydrogenation, filling and their subsequent inspection.
7.6 Cleanroom Gowning
In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment.
7.7 Aseptic Processing
In these lessons, we look at various manual and automated processes and facility layouts for vial filling operations.
7.8 Cleanroom Monitoring – Physical Tests
In this lesson, we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.
7.9 Quality System – Evaluation Activities
7.10 Maintenance Management
This lesson describes the processes and controls used in the delivery of maintenance services and work execution.

Week 8 – Controlling Cleanrooms and Automation

8.1 Site Master Planning – Part-II
We continue in this lesson exploring the configuration philosophy for a site specifically layering configuration options, fermentation/bioreactor, media and buffer preparation. We also look at the shaping and sizing options for fermentation, media preparation, buffer preparation, downstream processing, process and general utilities, buildings, and expansion.
8.2 Open Versus Closed Processing
8.3 Facility Layout Concept
8.4 Blow/Fill/Seal Technology
8.5 PLC Programming
In this lesson, we describe how to program a PLC to automate a machine using ladder logic diagrams.
8.6 PLC Program Case Studies
8.7 Cleanroom Monitoring – Microbiological Tests
In this lesson, we look at a range of typical microbiological measurements to monitor a cleanroom environment for conformance to specifications.
8.8 Cleanroom Monitoring – Cleanrooms Cleaning Procedures
8.9 Terminally Sterilised Products
8.10 EU Guidelines on Cleanroom Aseptic Preparation

Week 9 – Quality Systems for Cleanrooms

9.1 HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing
9.2 Batch Process Control
In this lesson, we discuss the ISA-88.01 modularization software standard for segmenting a process into physical entities, and into procedural models for instructional recipes. The physical model is used to describe equipment, and the procedural model used to describe recipes (process sequencing).
9.3 Nitrogen Supply and Distribution
9.4 Environmental Monitoring Program
In this lesson, we describe how to monitor a cleanroom environment in order to identify actual and potential sources of contamination using both physical and microbiological techniques.
9.5 ICH Q10 – Pharmaceutical Quality System
This lesson explains the concept of ‘continual improvement’ as part of a company’s quality management system and describes an effective corrective action process and a preventive action process (CAPA). It also gives details on the product-lifecycle for a pharmaceutical product and describes the monitoring of process performance and product quality.
9.6 FDA Guidance on Aseptic Processing

Week 10 – Construction Lifecycle for New and Modified Facilities

10.1 Construction Lifecycle
In the first lesson for construction lifecycle, we explore the following: choosing a construction type, substructure, options for super-structure, internal building fabric, mechanical installation, electrical & instrumentation, construction sequence for new build, constructability, construction management, construction safety, construction costs, schedule, and quality management. In the second lesson, we look at the contents of clean utility piping test packs. In the third lesson, we look at modular construction and sustainable construction.
10.2 Software Functional Block Diagram (FBD)
10.3 ASTM E 2500
In this lesson, we review the ASTM International standard E 2500 – 07 ‘Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment’.

Complete the Following Activities & Workshops

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

Complete an End of Module Assignment

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 and meet any regulatory requirements.

Week 11 – 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 12 – 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”
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 13 – Preparing for Process Validation

FDA Guidance for Process Validation (2011)

Week 14 – 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 15 – 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 16 – The Process Validation Report

Process Validation Report
Preparing for the Regulatory Audit
Periodic Review & Continuous Validation

Week 17 – Cleaning Validation

Cleaning Validation Strategy
Cleaning Validation Report

Week 18 – Health & Safety at the Operator/Product Interface

The Operator/Product Interface
Health & Safety Regulations