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 our program will rapidly help you get your CSV 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
Estimated salaries $35,000 – $75,000 (Based on US job data)
Application Deadline: Wednesday 17th March

Go Rapidly From Total Beginner to Advanced Level CSV Expert
Extend you or your team’s role into CSV projects
Estimated salaries €35,000 – €65,000 (Based on Irish job data)
Application Deadline: Wednesday 17th March

Approx. 120 hours to complete
Study Online 12hrs/week for 10 weeks or choose a faster/slower schedule
Weekly progress checks
Join 3010 learners

Apply NOW. Extend Your Role to Computer System Validation Projects

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

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 our Computer System Validation Training Course will rapidly help you get your Gamp and 21 CFR Part 11 projects under control!

Online Computer System Validation Training Course

Go Rapidly From Total Beginner to Advanced Level CSV Expert
Extend you or your team’s role into CSV projects
Estimated salaries $35,000 – $75,000 (Based on US job data)
Application Deadline: Wednesday 17th March

Go Rapidly From Total Beginner to Advanced Level CSV Expert
Extend you or your team’s role into CSV projects
Estimated salaries €35,000 – €65,000 (Based on Irish job data)
Application Deadline: Wednesday 17th March

Approx. 120 hours to complete
Study Online 12hrs/week for 10 weeks or choose a faster/slower schedule
Weekly progress checks
Join 3010 learners

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

See Pricing

Apply Now to Extend Your Role to CSV Projects

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

This Course is Right For You If…

You need to go Rapidly From Total Beginner to Advanced Level GAMP®5 and 21 CFR Part 11 Expert.
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 a broader understanding of how to manage data for LIMS using Computer System Validation.
10 Year Track Record. We’ve been delivering this program ONLINE for almost 10 years.

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

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 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

View Full Syllabus

Faq Price

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 5-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.

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?

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Syllabus Faq Price

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

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 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.