The ABCs of Computer System Validation -- CS100
build your essential skill set
Frustration, doubt, confusion, and sometimes anger cloud discussions of computer system validation in many companies.
This introductory workshop establishes a solid foundation for understanding the key concepts and skills needed to perform successfully in an FDA regulated environment. This workshop builds your basic skill set and focuses on the essential elements of computer system validation.
Topics
- Introduction to the FDA and the key regulations you need to know
- The overall computer system validation framework and deliverables
- The guidance documents for medical devices, pharmaceuticals, and clinical research software
- Test planning, execution, and documentation
- Writing clear and complete validation summary reports
- Typical pitfalls and perils that can derail a validation project
Who Should Attend?
- Computer system professionals new to a regulated environment
- Quality Assurance professionals new to software quality
- Computer system Project Managers who need to understand the regulatory landscape
- Validation team leads
- Protocol writers
- Anyone who needs to understand the framework of computer system validation established by FDA regulation
Prerequisites: None
Text/Materials Included: Course binder
Duration: 2 day workshop
Professional Development Credits: 16 PDUs
Cost: $950
Course Dates and Location: