Enroll in this course to learn…
- The key FDA and international regulations 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 4-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?
Some companies might call this role: CSV Engineer
- Starting Salary: €27,000 to €37,000
- After 2 Years: €37,000 to €48,000
- After 5 Years: €48,000 to €60,000
You are one of the following and can extend your role to cover Computer System Validation projects or manage data for LIMS.
- 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
- Laboratory Technician
- Biochemist
- Microbiologist
- Front/Backend Development or Enterprise Software
Some companies might call this role: CSV Engineer
- Starting Salary: $40,800
- After 2 Years: $51,000
- After 5 Years: $61,200
You are one of the following and can extend your role to cover Computer System Validation projects or manage data for LIMS.
- 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
- Laboratory Technician
- Biochemist
- Microbiologist
- Front/Backend Development or Enterprise Software
Delivered by an Industry Expert
Dr. Joe Brady
Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled
Dr. Joe Brady is 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.
Hear From People Who’ve Taken This Course
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.”
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.”
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.”
What Does the Online Classroom Look Like?
We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.