Computer System Validation Training Course (ONLINE). Extend Your Role to CSV Projects. Get Certified and Become a CSV Professional

Has the Computer System Validation Engineer left and you’ve been handed their responsibilities? Do the thoughts of your next audit fill you with dread? CSV can be frustrating but this program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment in compliance with FDA’s 21 CFR Part 11 or other regulatory guidelines using the GAMP framework.

  • Learn the process used to test, validate and formally document that a regulated GxP computerized system application does exactly what it is designed to do.

  • Go rapidly from beginner to advanced level CSV expert.

  • Extend you or your team’s role into CSV projects. Charge higher hourly rates.

  • Fully flexible online schedule to complement any work commitments and any pace of study.

  • Application Deadline: Wednesday 25th May
  • Study Online part-time
  • 12hrs/week for 10 weeks or choose a faster/slower schedule
  • Dedicated course leader who’ll check your progress at the end of every week and follow up with you to help you finish the course
  • Join 3010 learners
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Apply NOW. Extend Your Role to Computer System Validation Projects

End-of-week progress checks and follow-up by us to MAKE SURE you or your team finish the course.

Computer System Validation Course (ONLINE). Extend Your Role to CSV Projects. Get Certified and Become a CSV Professional

Has the CSV Engineer left and you’ve been handed their responsibilities? Do the thoughts of the next audit fill you with dread? CSV can be frustrating but this program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment in compliance with FDA’s 21 CFR Part 11 or other regulatory guidelines using the GAMP framework.
Online Computer System Validation Training Course

  • Learn the process used to test, validate and formally document that a regulated GxP computerized system application does exactly what it is designed to do.

  • Go rapidly from beginner to advanced level CSV expert.

  • Extend you or your team’s role into CSV projects. Charge higher hourly rates.

  • Application Deadline: Wednesday 25th May

  • Study Online part-time
  • 12hrs/week for 10 weeks or choose a faster/slower schedule
  • Dedicated course leader who’ll check your progress at the end of every week and follow up with you to help you finish the course
  • Join 3010 learners

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

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AstraZenega Logo

Novartis Logo

GSK Logo

Lilly Logo

Abbott Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

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Apply Now to Extend Your Role to CSV Projects

End-of-week progress checks and follow-up by us to MAKE SURE you or your team finish the course.

This course is right for you if…

  • You work with regulated data and have to ensure the following GxP computerized system applications are in compliance with regulatory guidelines such as 21 CFR Part 11.

    • Laboratory Information Management System (LIMS)
    • Clinical Trial Monitoring Systems
    • PLC for Controlled Packaging Equipment
    • Supervisory Control and Data Acquisition (SCADA)
    • Distributed Control System (DCS)
    • Chromatography Data System (CDS)
    • Enterprise Resource Planning (ERP) Systems
    • Manufacturing Execution System (MES)
    • Batch Record System
    • Building Management Systems (BMS)
    • Spreadsheets

  • You work in validation, automation or instrumentation and want to extend you or your team’s role, or your consultancy’s offer into Computer System Validation projects.

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

  • You work in a laboratory and need to manage regulated data for LIMS using Computer System Validation.

  • 10-year track record. We’ve been delivering this program ONLINE for over 10 years.

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

Enroll in this course to learn…

  • The key FDA and international regulations (EudraLex Volume 4 — Annex 11, ICH, WHO) 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 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)
  • Complete 8-question booklets (one for every week’s worth of content) which will summarise what you have learnt for the week and ensure you retain and understand the information.

You will write a 6,000-word report for senior management on a GxP computerized system application of your choice. 

You will outline the following:

  1. Identify and describe typical business and GMP functions
  2. Schematically represent typical architectural components
  3. Describe a general approach to achieving compliance and fitness for intended use over the entire lifecycle
    1. Concept
    2. Project
    3. Operation
    4. Retirement

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.
  • Create key validation deliverables, including validation plans, requirements specifications, test plans, validation tests (IQ, OQ, PQ), trace matrices, test summaries, and validation reports

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Minimum Entry Requirements

This program is highly specialized so you MUST have a solid understanding of GMP rules, regulations and guidelines.

AND you are any of the following…

  • Validation Engineer/Specialist or Senior Validation Manager
  • PhD, Masters or Degree in Biochemistry, Microbiology, Molecular Biology, Lab/Science, etc
  • Automation, Control/Instrumentation, Process, Chemical, Manufacturing, etc Engineer or Technician
  • Quality Assurance or Quality Control Technician or Specialist
  • Metrology, Maintenance Engineer, Technician or Specialist
  • Front/Backend Developer
  • Not sure if you meet the minimum requirements? Contact us.

NOTE: If you don’t have a solid understanding of GMP rules, regulations and guidelines, you need to start with our 6-Week GMP Training For Beginners in the Pharmaceutical Industry. (There’s a special price reduction for this GMP program if taken together with our CSV course. Contact us for details)

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.

The process is used to replace paper with electronic data within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing and make sure the system is:

  • completely transparent, robust and tamper proof
  • and can store those electronic data records so that they stand the test of time

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?
What are GxP Software Systems? View 10 Examples

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Your 10 Week Class Schedule:

Week 1 – Software Categories, Life Cycle Phases, and Operational Activities

  • 1.1 Drivers for Good Automated Manufacturing Practices
    In this lesson, we learn about the primary drivers behind the issuing of the Good Automated Manufacturing Practices guidance document and its focus.
  • 1.2 Life Cycle Phases of Computerized Systems
    In this lesson, we explore the lifecycle of a computerized system from its early specification to its retirement and upgrade.
  • 1.3 Computerized Systems in Regulated GxP Environments
    The objective of this lesson is to be able to describe a computerized system to a regulatory inspector to demonstrate the system is in control and fit for use.
  • 1.4 Good Automated Manufacturing Practices Software Categories
    In this lesson, we look at ways to categorize computerized system from infrastructural and off-the-shelf software to configurable and bespoke applications.
  • 1.5 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.
  • 1.6 Handover
    This lesson looks at ways to ensure that the environment into which the computerized system is to be received is prepared, to make sure that the system can be used and supported in a controlled manner.
  • 1.7 Product and Process Understanding
    This lesson makes recommendations about the application of subject matter expertise when supporting lifecycle activities for a computerized system amongst the end-user and the supplier.
  • 1.8 End-User Activities
    This lesson explains the responsibilities of the end-user when it comes to supporting the lifecycle activities for a computerized system.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 2.1 Record Anatomy
    In this lesson, we will describe the structure of a record in terms of the arrangement of data elements, and we will also discuss the ‘electronic record lifecycle.
  • 2.2 Records and Signatures required by 21 CFR Part 211 
  • 2.3 PLC Controlled Packaging Equipment
  • 2.4 SupervisoryControlandDataAcquisition(SCADA)
  • 2.5 DataFlowAnalysis
    In this lesson, we look at data flow analysis across systems to reveal where integrity could be compromised as the record lives in various computing environments associated with its creation, use, and retention.
  • 2.6 Example Records and Signatures Required by ICH Q7 

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 3.1 Supplier Activities
    This lesson explains the responsibilities of the supplier when it comes to supporting the lifecycle activities for a computerized system.
  • 3.2 Validation Planning
    In this lesson, we look at corporate and site level policy documents that define a regulated company’s overall approach to computerized system quality and compliance.
  • 3.3 Science-Based Quality Risk Management
    In this lesson, we look at suggestions about where to apply risk management throughout the lifecycle of a computerized system and how to manage the process for various categories of systems.
  • 3.4 Risk Management Considerations – Generic Hazards
    In this lesson, we look at an approach to conducting risk assessments on computerized systems based on their impact on product quality, patient safety and data integrity. We also list generic hazards for a computerized system associated with physical/environmental conditions, hardware and software, and human-related.
  • 3.5 Requirements Traceability Matrix (RTM)
    In this lesson, we introduce the Requirements Traceability Matrix (RTM); an important project document for tracing all user requirements to design specifications and appropriate verification tests.
  • 3.6 Efficiency Improvements (Continuous Improvements)
    In this lesson, we look at suggestions on ways to improve efficiencies throughout the lifecycle of a computerized system.
  • 3.7 Categorization of Laboratory Computerized Systems
    This lesson explains the GAMP® system for categorizing Laboratory Computerized Systems.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 4.1 HPLC Systems 
  • 4.2 Chromatography Data Systems (CDS) 
  • 4.3 GxP Records and Signatures Required by 11 CFR Part 820 
  • 4.4 Prerequisites for GERM
  • 4.5 Laboratory Information Management System (LIMS) 
  • 4.6 Identify Regulated Records and Signatures
    In this lesson, we describe why only those records required to meet GxP regulations, or submitted to regulators, should be identified as regulated electronic records.
  • 4.7 Electronic Production Records (EPR) 
  • 4.8 Impact Assessment of Electronic Records
    This lesson classifies regulated electronic records as High, Medium, or Low based on an assessment of the potential impact of the record on patient safety or product quality.
  • 4.9 Spreadsheets 

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 5.1 Organizational Change – Impact During Project Lifecycle
    This lesson looks at various ways to manage projects during episodes of major organizational changes.
  • 5.2 Outsourced IS/IT Environment
    Here we look at the contract considerations when we choose to outsource control of our IS/IT systems to a third-party vendor.
  • 5.3 I T Compliance – Key Concepts, and Infrastructure Elements
    In this lesson, we look at ways to standardize our IT Infrastructure Elements to facilitate and somewhat ‘modularize’ our compliance strategy.
  • 5.4 Development versus Implementation Life Cycle
    In this lesson, we describe how to implement various computerized systems based on their software category; where from a user’s perspective the lower categories require less vendor input and where the higher categories require more.
  • 5.5 Specification, Design and Verification
    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’.
  • 5.6 Testing Documentation Structure & Verification Terminology
    In this lesson, we look at good practices regarding the organization of testing documentation on a project and we also examine legacy and modern terms for testing documentation used in the medicinal products’ industries.
  • 5.7 Scalable Validation Deliverables
    This lesson recommends a range of scaleable validation deliverables over the range of software categories where we see increasing intricacy with increasing category designation.
  • 5.8 Patch and Update Management
    In this lesson, we consider suitable management strategies for the implementation of software patches and upgrades to an existing computerized system operating in a regulated environment.
  • 5.9 Operational Change and Configuration Management
    This lesson describes how to manage the configuration of a computerized system in a regulated environment during the operation and maintenance phase and keep it current and relevant where we’re in a period of continuous change and upgrading.
  • 5.10 Repair Activity
    In this lesson, we discuss a process by which non-functional systems are returned to a functional state under the control of a repair activity procedure.
  • 5.11 Periodic Review
    In this lesson we’re going to look at a method to ensure a computerized system remains compliant with regulatory requirements throughout its operational life, remains fit for intended use, and continually satisfies company policies and procedures.
  • 5.12 Backup and Restore
    In this lesson, we describe a mechanism to protect electronic information assets against loss of original data and subsequent accurate restoration of assets when required.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 6.1 Good Electronic Records Management Transactions
    In this lesson, we look at current good practices associated with good electronic records management including transactions, audit trails, sequence checks, electronic signatures, and continuous session system access.
  • 6.2 Audit Trails
    In this lesson, we explore how the application of audit trails improve information quality and reduce information loss from activities such as overwriting of data attributes.
  • 6.3 AutoCAD Used for Managing Pack Drawings
  • 6.4 Building Management Systems (BMS) 
  • 6.5 21 CFR Part 211 – Subparts D and J
    In this lesson we look at the FDA’s predicate GMP rule 21 CFR Part 211 specifically Subparts D and J. Subpart D relates to ‘Equipment’ and how subpart J relates to ‘Records and Reports’.
  • 6.6 FDA 21 CFR Part 11 – ‘Electronic Records; Electronic Signatures (ERES)’ 

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 7.1 Electronic Data Archiving
    In this lesson, we describe a suitable data archiving strategy for moving data that is no longer actively used in the active environment where it was created to a separate data storage area for long-term retention.
  • 7.2 Typical Tasks Supporting Validation
    Here we look at recommendations from the FDA regarding tasks that may support the validation of a computerized system in a regulated environment.
  • 7.3 Security Management
    In this lesson, we define the controls required for securing a computerized system in an operational environment.
  • 7.4 Business Continuity Management
    In this lesson, we discuss how to regain access to an IT system and its data following a disaster, and how to restore critical business processes following a disruption while continuing to provide products or services.
  • 7.5 Relationship Between System Backup, Archival, and Disaster Recovery
    In this lesson we look at the inter-relationship amongst the accurate and reproducible backing up of digital assets (data and software), the archiving of closed business transactions and master data relocation to an external system, and the regaining of access to an IT system (including software, hardware and data) following a disaster.
  • 7.6 System Retirement, Decommissioning and Disposal
    This lesson describes appropriate controls that need to be in place when removing a computerized system from day to day use through obsolescence or replacement.
  • 7.7 Copies of Records
    This lesson considers methods on how to preserve the content and meaning of an electronic record when making a copy.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

  • 8.1 Complying with 21 CFR Part 11 ERES – Types of Controls Required 
  • 8.2 ERES – Key Areas for Guidance – Where to Apply Electronic Signatures
    This video explores examples of where to apply electronic signatures required by predicate rules and required by internal procedures.
  • 8.3 Batch Record Systems 
  • 8.4 Enterprise Resource Planning (ERP) Systems 
  • 8.5 Controls to Maintain Electronic Record Integrity
    In this lesson, we examine controls to maintain electronic record integrity when creating and
    storing records, transmitting records, and archiving records, and also controls for signature certification/ authentication and signature link integrity.
  • 8.6 Risk Controls for Electronic Records 
  • 8.7 Risk Controls for Electronic Signatures
    In this lesson, we look at risk controls for electronic signatures in terms of instruction for the information associated with a signed electronic record, e-signatures security certificates, and signature controls.
  • 8.8 User ERES Responsibilities
    In this lesson, we look at the end-user’s responsibilities associated with electronic records and electronic signatures.
  • 8.9 Supplier ERES Responsibilities
    In this lesson, we look at the supplier’s/vendor’s responsibilities associated with electronic records and electronic signatures.

Deliverables

  • Complete a question booklet that will summarise what you have learnt for the week and help ensure you retain and understand the information.

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.

Delivered by a Practicing Industry Expert

Dr.Joe Brady Lecturer at GetTeskilled

Dr. Joe Brady

Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled

Dr. Joe Brady is a 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 twenty years of project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.

Syllabus   Faq   Price

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.”

If you’re spending money on an education program, make sure you choose one you’ll finish!

With every GetReskilled ONLINE program;

  1. We use one centralized platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires you to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
  2. Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
  3. We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
  4. You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.

This all helps us to spot any potential issues early and helps you completely finish the program.

How-does-Studying-Online-Work

Start Your Application

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

Apply NOW. Extend Your Role to Computer System Validation Projects

End-of-week progress checks and follow-up by us to MAKE SURE you or your team finish the course.

End-of-week progress checks and follow-up by us to MAKE SURE you or your team finish the course.

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

Complete all assessments and the end of module written assignment to get certified in Computer System Validation.

Add details of your certificate to your CV/Resume or your LinkedIn profile.

Computer System Validation Certificate

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13 Frequently Asked Questions

Is this course delivered online?

Yes, this program is delivered fully online.

  1. Click on the “Apply Now” button and fill out the application form.
  2. A member of our team will telephone you (within one or two working days) and chat through your application and make sure both you and the course are a good fit for each other. Please note: We may sometimes suggest a different course to the one you’ve applied for if it’s a better fit or a better way to get you to an employable level of knowledge sooner.
  3. After the telephone call, we will email you details of the telephone conversation covering:
    1. Course Overview
    2. Course Content
    3. Course Delivery & Certification
    4. Course Fees
    5. Registration Deadline, Start Dates and How to Register
    6. Link on the Online Registration Form
  4. You MUST complete the Online Registration Form to confirm your place on the course (It should take about 5 to 10 minutes to fill out the online registration form). Once completed, we will send an email acknowledgement confirming your registration.
  5. Our Course Director will telephone you just after the application deadline to arrange payment details.
  6. We will email your username, password and a link to your course on the course start date.
  7. Start your course!

Yes, a number of our students have their employers pay for this program.

We can invoice your employer (with or without a purchase order) for payment. First, you need to provide us with your employer details so we can prepare the invoice. You can share these details in our follow-up phone call or we can email you an outline of the information we need and have your employer respond.

Or you can pay by company credit card or bank transfer.

Yes, for an additional $500USD we can start you within 24 working hours Click here to “Request an “FAST” Start”

Yes

No you don’t. The online classroom is open 24 hours a day so you do not have to login at any particular time. We will give you a Username and Password on the day the program starts and this allows you 24 hours a day access.

Each session of online content typically includes 6-10 topics. Each topic includes:

  • A set of course notes – these provide additional depth to the video content.
  • Warm-up self-assessment question – to recap or activate any relevant prior learning.
  • A video – these are typically 5-15 minutes long and deliver 80% of the course content.
  • Post video self-assessment questions to check how well you can recall this new material from memory.
  • Any follow up assessments or assignments.

Yes

Yes, you can speed up or slow down the rate of delivery to suit your requirements. The most important thing is communication between you and your course coordinator. If you are taking a break or are busy at work and do not have time to study you need to tell her or him. Similarly, if you want to study at a faster rate, then just email in good time and ask for more course content.

Yes

No, universities generally don’t offer university accreditation for just a single module. However, this module is currently being delivered as part of a Masters in Validation Technology by Technological University Dublin, Ireland. See link. https://www.tudublin.ie/study/postgraduate/courses/pharmaceutical-validation-technolo

Yes for 6 months

No, I’m afraid we can’t find you a job