Online Computer System Validation Training Course

Computer System Validation Training Course. Retrain ONLINE for CSV Projects

Do the thoughts of your next audit fill you or your team with dread? You’re not alone. CSV can be frustrating but our ONLINE program will rapidly help you get your GAMP®5 and 21 CFR Part 11 projects under control!

  • Go Rapidly From Total Beginner to Advanced Level CSV Expert
  • Extend you or your team’s role into CSV projects
  • Application Deadline: Wednesday 15th January
Price $2,999

Computer System Validation Course. Retrain ONLINE for CSV Projects

Do the thoughts of the next audit fill you with dread? You’re not alone. CSV can be frustrating but our program will rapidly help you get your GAMP®5 and 21 CFR Part 11 projects under control!
Online Computer System Validation Training Course

Pfizer Logo

Abbott Logo

Lilly Logo

Novartis Logo

Amgen Logo

GSK Logo

ESTIMATED SALARY
$40k to $82k
Based on US job data

ESTIMATED SALARY
€27k to €65k
Based on Irish job data

DURATION
1 Module – 10 Weeks
Study Online 14 hrs/week 

LEVEL
Beginner – Advanced
Join 3013 Learners

APPLY BY
Wednesday 15th January
Class Starts: 23rd January

Price   Syllabus   FAQ   Apply
Apply Now to Become a Computer System Validation Professional

This Course is Right For You If…

  • You work in Validation or Automation and want to extend your role to CSV.

  • You want to extend your consultancy’s offer into CSV projects.

  • You work in a laboratory and need a broader understanding of what CSV means for a lab system.

  • You have a hectic work and home schedule and can’t afford 3, 4 or 5 days out of the office.
  • You don’t want to waste your time, money or training budget on hotel or travel junkets.

Apply Now to Become a Computer System Validation Professional

100% Privacy Guaranteed

This Course is Right For You If…

  • You work in Validation or Automation and want to extend your role to CSV.
  • You work in a laboratory and need a broader understanding of what CSV means for a lab system.

  • You want to extend your consultancy’s offer into CSV projects.
  • You need to go Rapidly From Total Beginner to Advanced Level GAMP®5 and 21 CFR Part 11 Expert.

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

Enroll in this course to learn…

  • The key FDA and international regulations and guidance regarding CSV and which apply to your company
  • How the CSV process fits into your Software Life Cycle and the purpose of each validation deliverable
  • The principles of your software quality assurance and how to manage the auditors’ expectations around its key components
  • The software validation life cycle from design, through construction, installation and live start-up
  • The regulations governing the use of electronic records and signatures in a regulated environment
  • The methodology and implementation model for a risk-based approach to CSV

You’ll produce a number of deliverables throughout course including…

  • Determine the end user supplier activities during the lifecycle of a computerized system
  • Identify where you would use risk based decision making throughout the lifecycle of a computerized system
  • Prepare a configuration management process flow diagram and identify where to use change control
  • Define the content of typical logs and accompanying records for both incident management and corrective and preventive action (CAPA)
  • Determine suitable risk controls when assessing electronic records and electronic signatures
  • Leverage risk-based decision making in your software quality assurance procedures

And take the following skills and knowledge back to work…

  • Be able to apply the FDA and international regulations to your current projects
  • Use Risk based decision when making an assessment to see what software does or does not require validation, ensure critical risks are identified and the correct level of validation is carried out.
  • Leverage risk-based decision making in your software quality assurance procedures
  • Create key validation deliverables, including validation plans, requirements specifications, test plans, validation tests (IQ, OQ, PQ), trace matrices, test summaries, and validation reports
Price   Syllabus   FAQ   Apply

Entry Requirements

You have…

  • An understanding of GMP rules, regulations and guidelines

OR you are a…

  • Validation Engineer or Specialist
  • Senior Validation Manager
  • Automation Engineer
  • Control/Instrumentation Engineer
  • Process Engineer or Project Engineer
  • Quality Assurance or Quality Control Specialist
  • Maintenance Engineer or Technician

OR…

  • Laboratory Technician
  • Biochemist
  • Microbiologist

OR…

  • Front/Backend Development or Enterprise Software.

Add On Program: If you don’t have experience working in a GMP manufacturing environment, you need to start with our 4-Week GMP Training For Beginners For The Pharmaceutical Industry.

What is Computer System Validation (CSV)?

Computer Systems Validation (CSV) is a process used to ensure (and document) that all computer-based systems will produce information or data that meet predefined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended.

What is a CSV Specialist?

CSV specialists plan, write, implement and review the Computer Systems Validation protocols in place within highly regulated manufacturing industries. Their work is essential to make sure that all computer-based systems are operating as intended (with documents to prove it) to meet regulatory requirements.

There is currently a high demand for trained Computer System Validation Specialists. As a result, salaries are highly competitive.

Need More Detailed Information?
What is Computer System Validation (CSV)?
What is a CSV Specialist?

Image showing Computer System Validation professional wearing personal protective equipment
Price   Syllabus   FAQ   Apply

Your 10 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.

  • Drivers for GAMPS.
  • GAMP®5 Software Categories
  • Operational Activities
  • Life Cycle Phases of Computerized Systems
  • Computerized Systems in Regulated GxP Environments
  • Handover
  • Product and Process Understanding
  • End User Activities
  • Electronic Record Content, Structure and Context, and Record Anatomy
  • Records and Signatures required by 21 CFR Part 211
  • PLC Controlled Packaging Equipment
  • Supervisory Control and Data Acquisition (SCADA)
  • Data Flow Analysis
  • Example Records and Signatures Required by ICH Q7
  • Supplier Activities
  • Validation Planning
  • Science Based Quality Risk Management
  • Risk Management Considerations Generic Hazards
  • Requirements Traceability Matrix (RTM)
  • Efficiency Improvements (Continuous Improvements)
  • Categorization of Laboratory Computerized Systems
  • HPLC System
  • Chromatography Data System (CDS)
  • GxP Records and Signatures Required by 21 CFR Part 11
  • Prerequisites for Good Electronic Records Management
  • Laboratory Information Management System (LIMS)
  • Identify Regulated Records and Signatures
  • Electronic Production Records (EPR)
  • Impact Assessment of Electronic Records
  • Spreadsheets
  • Organizational Change
  • Outsourced IS/IT Environment
  • IT Compliance
  • Development versus Implementation Life Cycle
  • ASTM E 2500 – 07
  • Testing Documentation Structure & Verification Terminology
  • Scalable Validation Deliverables
  • Patch and Update Management
  • Operational Change and Configuration Management
  • Repair Activity
  • Periodic Review
  • Backup and Restore
  • Good Electronic Records Management Transactions
  • Audit Trails
  • AutoCAD Used For Managing Pack Drawings
  • Building Management Systems (BMS)
  • FDA Predicate Rule 21 CFR Part 211 – Subparts D and J
  • FDA 21 CFR Part 11 – ‘Electronic Records; Electronic Signatures’ (ERES)
  • Electronic Data Archiving Part
  • Typical Tasks Supporting Validation (B)
  • Security Management
  • Business Continuity Management
  • System Retirement Decommissioning and Disposal
  • Copies of Records
  • Complying with 21 CFR Part 11 ERES – Types of Controls Required
  • Complying with 21 CFR Part 11 – Key Areas for Guidance
  • Batch Record System
  • Enterprise Resource Planning (ERP) Systems
  • Controls to Maintain Electronic Record Integrity
  • Risk Controls for Electronic Records
  • Risk Controls for Electronic Signatures
  • User ERES Responsibilities
  • Supplier ERES Responsibilities
Prepare a report to identify different types of computerized systems and explain how from data-flow analysis potential source of undesired events or where record integrity could be compromised? Then specify an electronic record for one system and the main categories of controls to maintain its integrity and compliance to 21 CFR Part 11 and the signatures required by 21 CFR Part 211, 21 CFR Part 820 and ICH Q7.
You will produce a number of deliverables during the course including:

  • Determine the end user supplier activities during the lifecycle of a computerized system
  • Identify where you would use risk based decision making throughout the lifecycle of a computerized system
  • Prepare a Configuration Management Process Flow Diagram and identify where to use Change Control
  • Define the content of typical logs and accompanying records for both incident Management and corrective and preventive action (CAPA)
  • Determine suitable risk controls when assessing electronic records and electronic signatures.
Price   Syllabus   FAQ   Apply

What Kind of Roles Would I be Suitable For?

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

Some companies might call this role: CSV Engineer

Online Computer System Validation Training Course
  • Starting Salary: €27,000 to €37,000
  • After 2 Years: €37,000 to €48,000
  • After 5 Years: €48,000 to €60,000

You are one of the following and can extend your role to cover Computer System Validation projects or manage data for LIMS.

  • Validation Engineer or Specialist
  • Senior Validation Manager
  • Automation Engineer
  • Control/Instrumentation Engineer
  • Process Engineer or Project Engineer
  • Quality Assurance or Quality Control Specialist
  • Maintenance Engineer or Technician
  • Laboratory Technician
  • Biochemist
  • Microbiologist
  • Front/Backend Development or Enterprise Software

Some companies might call this role: CSV Engineer

Computer System Validation Course. Learn From Experts
  • Starting Salary: $40,800
  • After 2 Years: $51,000
  • After 5 Years: $61,200

You are one of the following and can extend your role to cover Computer System Validation projects or manage data for LIMS.

  • Validation Engineer or Specialist
  • Senior Validation Manager
  • Automation Engineer
  • Control/Instrumentation Engineer
  • Process Engineer or Project Engineer
  • Quality Assurance or Quality Control Specialist
  • Maintenance Engineer or Technician
  • Laboratory Technician
  • Biochemist
  • Microbiologist
  • Front/Backend Development or Enterprise Software

Delivered by an Industry Expert

Our Team

Dr. Joe Brady

Full-Time Validation Lead and Lecturer, Technological University Dublin

Dr. Joe Brady is full-time practicing Validation Lead and an assistant lecturer with Technological University Dublin (TU Dublin), 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.

Price   Syllabus   FAQ   Apply
Hear From People Who’ve Taken This Course
Drivers for GAMPS.

Ken O’Keeffe

“Interesting and Helpful in my Current Role”

“I have found the Computer System Validation course to be both interesting and helpful in my current role. The individual sections of the course are easy to follow. The delivery of the course is really straight forward. During the course there has been times when I have been busy with work and have not been able to study. The structure of the course allows me to be flexible in my study.”

Computer System Validation Course

Giorgia Romeo

“I Would Highly Recommend This Course”

“I would highly recommend anyone wishing to gain an education in the Computer System Validation sector to do this course. For me it has been very useful studying on-line in order to do the course in my own time. Lessons are very clear and the assignment deadlines make you disciplined to meet the deadlines set.”

Computer System Validation

John Ryan

“The Course Material is Concise and Interesting”

“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 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.”

What Does the Online Classroom Look Like?

How-does-Studying-Online-Work

We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.

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, we check your progress weekly to keep you on track and we’ll reach out to you by email or even by phone if you fall behind!
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.

Start Your Application

Get certified and extend you or your team’s role to CSV Projects

Apply Now to Become a Computer System Validation Professional

Talk To Our Team

USA/World
Call Geraldine: +1 (617) 901 9268

Ireland
Call Sinead: +353 (0)21 2409016

Show Off Your New Skills: Get a Computer System Validation Certificate of Completion

Once the course is over, complete a written assignment to get certified in Computer System Validation

Add it to your resume, your LinkedIn profile or just get that well-earned raise you’ve been waiting for.

Computer System Validation Certificate

GetReskilleld is an authorized LinkedIn education provider

You can add your education, certificates and everything you learned and earned at GetReskilled into the Education section of your profile.

GetReskilled LinkedIn

Join our Students who are working for:

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

Price   Syllabus   FAQ   Apply

Frequently Asked Questions

  • Is this course delivered online? Yes
  • Can I request a fast start? Yes, for an additional $500USD we can start you within 24 working hours Click here to “Request an "FAST" Start”
  • Can I pause the class if I get to busy at work or because of family commitments? Yes
  • Are all course materials available 24/7? Yes
  • Can I take this program at an accelerated pace and finish it sooner that 10 weeks? Yes it's possible. Talk to us for details.
  • Do I need to be online all the time? No you don't
  • I live in the UK/Europe/USA/Australia etc,. Can I still take this program? Yes
  • Can I have my employer pay for this? Yes
  • Can I spread the payments over a couple of months? Yes
  • Will I have my own personal course leader who follows up with me to make sure I get to the end of the course Yes
  • Will I have access to the materials after the course is finished? Yes for 6 months
  • Will you find me a job in CSV at the end of the course? No, I'm afraid we can't find you a job

Price

Price