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.
Application Deadline: Wednesday 2nd October

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

Computer System Validation Course. Learn From Experts

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

Computer System Validation (CSV) Training Course for Industry Professionals

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 Total Beginner to Advanced Level CSV Expert
Extend you or your team’s role into CSV projects
Application Deadline: Wednesday 2nd October

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

See Course Price

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.

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.

Enrol 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:

Identify and describe typical business and GMP functions
Schematically represent typical architectural components
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

View Full 10 Week Syllabus

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)

See Course Price

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

With every GetReskilled ONLINE program;

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.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
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.
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.

Meet Your Online Classroom Support Team

When you learn at GetReskilled, you can always rely on an in-house team of experts to provide guidance and support, whenever you need it.

Course Leaders

Your Course Leaders will onboard you on the program, and help keep you motivated throughout the course.

Course Coordinators

Your CC’s are here to provide you with answers, tips, and are going to check your progress weekly to keep you on track and will reach out to you by email or even by phone if you fall behind!

Here from people who have take this course

Renato Chato

“This course was very informative and could greatly enhance our knowledge and understanding on Pharma Manufacturing practices (GMP, GDP, etc.). The training experience was great and details were clear. Keep it up, guys!”

Michael Cheong Yim Poh

“Once you tune in your mind set to studying online, it’s a great way to learn as you manage the pace yourself.”

Delivered by an Industry Expert

Dr. Joe Brady

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

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 programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institutions.

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 Singapore, China, Ireland, The Netherlands, Belgium, 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

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.

Week 2 – Record Anatomy and Data Flow Analysis

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

Week 3 – Science Based Quality Risk Management and Validation Planning

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.

Week 4 – Identify Regulated Records and Signatures, and Impact Assessment of Electronic Records

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

Week 5 – Specification and Verification, Scalable Validation Deliverables and Configuration Management

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.

Week 6 – Good Electronic Records Management Transactions, and Audit Trails

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)’

Week 7 – Electronic Data Archiving, Business Continuity Management, and System backup, Archival, and Disaster Recovery

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.

Week 8 – Controls to Maintain Electronic Record Integrity, and Risk Controls for Electronic Signatures

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.

Week 9 & 10 - Competency Based Assessment

The end of module assessment is a competency based open book exam where you will need to answer 8 essay style questions. Each essay will require about half a page to one page to answer. Your answer will be assessed as either competent or not yet competent. In addition, you will also have a 15 minute oral interview with our Subject Matter Experts.

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.

Certified by DPS Education

You will receive an end of course certificate from DPS Education subject to the following criteria;

The submission of all assessments and the end of module assignment.

Show Off Your New Skills: Get a Certificate of Completion

Complete all assessments and the end of module written assignment to receive a Certificate of Award in “Computer System Validation“.

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

Price

S$1,299/month

For 3 Months

S$3,499 in Advance

Save S$398

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

Application Deadline: Wednesday 2nd October

Course Starts: 9th October

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Apply NOW. Extend Your Role to Computer System Validation Projects

Contact Us

Singapore
Call Geraldine: +(65) 6513 9500

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Frequently Asked Questions

How do you keep track of my progress on the course?

We release only one week’s worth of material at a time and then check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. There is a “Progress Bar “on your course which is helpful to you and us to know how you are doing.

You have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind. She’ll also be in touch weekly to let you know when new content is open for you.

Is this program delivered online?

Yes, this program is delivered fully online.

What does a typical week look like?

Each week 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 5-10 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. If you can’t answer these questions, you should revisit that topic’s learning materials.
Any follow up assessments or assignments.

How many hours a week must I do for the course?

Most students report between 8-14 hours per week.

Do I need to be online all the time?

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.

Can I pause the class if I get to busy at work or because of family commitments?

Yes.

Can I take this course at a faster pace?

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.

Will I have access to the materials after the course is finished?

Yes for 6 months.

Is this course relevant to both pharmaceutical and medical device manufacturing industries?

Yes, this course is relevant to both the pharmaceutical and medical device industries.