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 2nd December

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 for the world’s biggest pharma and medical device companies

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 2nd Dec
Class Starts: 10th Dec

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.

Minimum Entry Requirements;

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

  1. Do you have a sound understanding of GMP rules, regulations and guidelines?
  2. Can you read engineering documentation such as P&IDs and piping isometrics?
  3. Do you understand IQ, OQ and PQ?
  4. 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.

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

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

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

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.

  • 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/labeling 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.
  • 1.8 Introduction to ISO 9001:2008
    This lesson is about the key requirements of a quality management system.
  • 1.9 Typical GMP list for drug substance
    This presentation explores the content of ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”.
  • 1.10 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.
  • 1.11 GMP for Personnel
  • 1.12 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.
  • 1.13 Maintenance: Good and Best Practices
    In this lesson, we describe basic and good practices associated with maintenance in a regulated environment.
  • 2.1 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.
  • 2.2 Plant Layout 
    In these presentations, 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.
  • 2.3 Zoned Air-Conditioning Systems
    In this presentation, we look at a practical example where a HVAC system can be dynamically operated to control the temperature of a room (space
  • 2.4 Isolator Technology 
    In this lesson, we explain the principals behind the use of ‘isolators’ and Restricted Access Barrier Systems (RABs) for critical ‘open processing’ operation
  • 2.5 Cell Breakage
    In this lesson, we describe a mechanism for bacterial cell disruption for the recovery of intracellular products.
  • 2.6 Purified Water (PUW) Generation, Storage and Distribution 
    In these presentations, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • 2.7 Clean Room and Clean Air Device monitoring 
  • 2.8 Good Engineering Practices Procedures
    In this presentation, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
  • 2.9 GMPs for Buildings and Facilities 
  • 2.10 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.
  • 2.11 Maintenance Program
    In this lesson, we describe the key aspects of a typical maintenance program.
  • 3.1 Conceptual Design – Part-1
    In this lesson, we begin to explore a quantified effort in how to size, shape, program and cost an investment.
  • 3.2 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.
  • 3.3 Plant Automation
    This lesson is an introduction to conventional process control using one-way digital and analog signals
  • 3.4 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.
  • 3.5 Clean Steam Generators 
    The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
  • 3.6 Steam Sterilization in Place
    In these presentations, we look at the mechanism behind the sterilization of process equipment using saturated steam.
  • 3.7 GMPs for Process Equipment 
  • 3.8 Quality Systems – Resources
    In this lesson, we describe what resources need to be allocated for a quality system and operational activities.
  • 4.1 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.
  • 4.2 Air Flow Patterns 
    In these presentations, 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.
  • 4.3 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.
  • 4.4 Filter Ratings 
    In these presentations, 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)’.
  • 4.5 Logic Gates Functions and PLC 
  • 4.6 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
  • 4.7 Good Engineering Practices Procedures 
  • 4.8 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.
  • 4.9 Maintenance- Work Execution
    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.
  • 5.1 Site Master Planning – Part-I
    In this lesson, we take our first look at a 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
  • 5.2 Classification of Clean Areas – Vial Filling 
    In these presentations, 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.
  • 5.3 Area Classification Protection
    In this lesson, we observe a range of airlock configurations typically used in combination safety 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.
  • 5.4 Compress Air and Pneumatics
  • 5.5 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.
  • 5.6 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
  • 5.7 Aseptic Processing 
    In these presentations, we look at various manual and automated processes and facility layouts for vial filling operations.
  • 5.8 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.
  • 5.9 Quality System – Evaluation Activities 
  • 5.10 Maintenance Management
    This lesson describes the processes and controls used in the delivery of maintenance services and work execution.
  • 6.1 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.
  • 6.2 Open Versus Closed Processing
  • 6.3 Facility Layout Concept 
  • 6.4 Blow/Fill/Seal Technology 
  • 6.5 PLC Programming
    In this lesson, we describe how to program a PLC to automate a machine using ladder logic diagrams.
  • 6.6 PLC Program Case Studies
  • 6.7 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.
  • 6.8 Cleanroom Monitoring – Cleanrooms Cleaning Procedures 
  • 6.9 Terminally Sterilised Products
  • 6.10 EU Guidelines on Cleanroom Aseptic Preparation 
  • 7.1 HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing 
  • 7.2 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).
  • 7.3 Nitrogen Supply and Distribution
  • 7.4 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.
  • 7.5 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.
  • 7.6 FDA Guidance on Aseptic Processing 
  • 8.1 Construction Lifecycle
    In the first class 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 video, we look at the contents of clean utility piping test packs. In the third video we look at modular construction and sustainable construction.
  • 8.2 Software Functional Block Diagram (FBD) 
  • 8.3 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’.
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.

You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Technological University Dublin (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.

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.