Education and Training in Pharma
Computer System Validation Course. Learn From Experts
Computer System Validation Course

Computer System Validation (CSV) Training Course for Industry Professionals

Do the thoughts of your 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!
  • Go Rapidly From Total Beginner to Advanced Level CSV Expert
  • Turn Your Work Experience into an Advanced Certification
  • Part-time, Online. No Needless Travel
  • Application Deadline: 21st November
Price $2,499

Computer System Validation (CSV) Course for Industry Professionals

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!
Computer System Validation Course. Learn From Experts Course GetReskilled
Computer System Validation
Computer System Validation Course
21 CFR Part 11
Electronic Data Archiving Part
Good Electronic Records Management Transactions
Record Anatomy and Data Flow Analysis

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

APPLY BY
21st November
Class Starts: 29th November

LEVEL
Beginner – Advanced
Join 3013 Learners

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

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

Apply NOW to Become a Computer System Validation Professional

What this course will teach you:

Apply NOW To Become a Computer Systems Validation Professional

100% Privacy Guaranteed

  • Go Rapidly From Total Beginner to Advanced Level CSV Expert
  • Turn Your Work Experience into an Advanced Certification
  • Part-time, Online. No Wasted Travel
  • Application Deadline: 21st November

What this course will teach you:

Entry Requirements

You need firsthand factory floor experience working in a GMP regulated manufacturing environment.

NEED TO PREPARE? Don’t have experience working in a GMP regulated manufacturing environment? Then take our “Manufacturing Safe Medicines (Foundation Course) and get rapidly up to speed.

This Course is Right For You If;

  • The CSV Engineer just left and you’ve been handed all their responsibilities
  • You need a program that takes you rapidly from a Total Beginner to an Advanced Level
  • You need to apply GAMP®5 and 21 CFR Part 11 at work on a daily basis
  • You don’t want to waste your time, money or training budget on hotel or travel junkets.

OR

  • You’re an Automation Engineer who works or wants to work in Pharma/MedTech.

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

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.

Automation Engineers, apply for roles that require CSV in the Pharam/MedTech sector:

Computer System Validation Course. Learn From Experts
  • Starting Salary: €45,000+
  • After 2 Years: €50,000+
  • After 5 Years: €65,000+

Some companies might call this role: CSV Engineer

Computer System Validation Course. Learn From Experts
  • Starting Salary: €27,000 to €37,000
  • After 2 Years: €37,000 to €48,000
  • After 5 Years: €48,000 to €60,000
Computer System Validation Course. Learn From Experts
  • Starting Salary: $55,200
  • After 2 Years: $69,000
  • After 5 Years: $82,800

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

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.
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.”

Start Your Application

Click below to start your application.

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

Your Lecturer

Our Team

Dr. Joe Brady

Full-Time Validation Lead and Lecturer, Dublin Institute of Technology

Dr. Joe Brady is full-time practicing Validation Lead and an assistant lecturer with the Dublin Institute of Technology (DIT), 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.

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.

Week 1 – Software Categories, Life Cycle Phases, and Operational Activities
  • 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
Week 2 – Record Anatomy and Data Flow Analysis
  • 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
Week 3 – Science Based Quality Risk Management and Validation Planning
  • 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
Week 4 – Identify Regulated Records and Signatures, and Impact Assessment of Electronic Records
  • 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
Week 5 – Specification and Verification, Scalable Validation Deliverables and Configuration Management
  • 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
Week 6 – Good Electronic Records Management Transactions, and Audit Trails
  • 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)
Week 7 – Electronic Data Archiving, Business Continuity Management, and System backup, Archival, and Disaster Recovery
  • Electronic Data Archiving Part
  • Typical Tasks Supporting Validation (B)
  • Security Management
  • Business Continuity Management
  • System Retirement Decommissioning and Disposal
  • Copies of Records
Week 8 – Controls to Maintain Electronic Record Integrity, and Risk Controls for Electronic Signatures
  • 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
Week 9 & 10 Complete an End of Module Assignment

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.

Complete the Following Activities & Workshops

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.

Show Off Your New Skills: Get a 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 Course

Join our Alumni who are working for:

pfizer company logo
abboutt company logo
novartis company logo
lilly company logo
roche company logo
amgen company logo
sanofi aventis company logo
gsk company logo

Frequently Asked Questions

  • Is this course delivered online? Yes
  • 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.

Price

Price

Price

Price

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

Application Deadline: 21st November, 2018

Program Starts: 29th November

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Please Note: There is an acute shortage of people with CSV Skills especially in the Republic of Ireland which has experienced a huge resurgence in construction in the last two years.

Start Your Application

Click below to start your application.

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

Got More Questions?

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