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.
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
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?