Description
21 CFR Part 11 is the regulatory framework that this course is based on. It will provide a quick summary of CSV activities. The concepts of CSV, as well as various aspects of validation, will be discussed. This training will cover essential principles and an overview of computer systems compliance in general. The categorization of software and hardware according to GAMP 5, along with different validation techniques, are all part of this course. Developing URS, FRS, FAT, SAT, IQ, OQ, and PQ will also be reviewed.
Courses Outcomes
By the end of the course, you will be able to:
- Understand the provisions of 21 CFR Part 11
- Categorize software and hardware according to GAMP
- Develop a URS, FRS, FAT, SAT, IQ, OQ, and PQ
- Understand different validation techniques
- Apply the concepts of CSV in real-world scenario
Who Should Attend
This course is beneficial for CSV professionals, software and hardware developers, quality assurance personnel, validation engineers/managers, and project managers. It will also be useful for those who want to enter the CSV field. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers) can also take this course.
