This course is right for you if…
You don’t need to be able to code to work in CSV
One of the single biggest misconceptions of working in Computer System Validation is that you need to be able to code or have a computer science background or be able to program a PLC.
This is not the case as CSV is about managing data accuracy, reliability and integrity, not programming.
However, we do sometimes see a requirement for the ability to code in some roles where the job description overlaps with automation engineering. And you do need solid experience using the GxP computer process you will be validating and understand its functional layout.
Enroll in this course to learn…
- The key FDA and international regulations (EudraLex Volume 4 — Annex 11, ICH, PICs) 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 technical report for senior management on a GxP computerized system application of your choice. You can choose a project from work for this!
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
- Concept
- Project
- Operation
- Retirement
This report will demonstrate:
- Your understanding of how the electronic data from the system is managed to make sure it is transparent, robust and tamperproof, that it is stored so that it stands the test of time
- That the systems and procedures have been put in place to ensure that nothing crashes and no data is lost and that the necessary ERES considerations have been included.
Our CSV expert will give you written feedback on your assignment.
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
See Course Price
Minimum Entry Requirements
“You don’t need to be able to write code or have a computer science background to work in computer system validation”
However, you must have solid experience using at least one GxP computer process and understand its functional layout.
In addition…
This program is highly specialized so you MUST have a solid understanding of Good Manufacturing Practices (GMPs) 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)?
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 Engineer?
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 Engineers. As a result, salaries are highly competitive.
Need More Detailed Information?
What is Computer System Validation (CSV)?
What is a CSV Engineer?
What are GxP Software Systems? View 10 Examples
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