Computerized System Validation (CSV)
Computer Aided Drug Design (CADD)
Introduction to Pharmaceutical Science
The computerization of healthcare is more than simply a regulatory requirement. It not only lowers risk but also increases system understanding throughout project implementation and mandates a well-defined, structured execution of the project. Validation of pharmaceutical computer systems has the potential to save money and time for businesses by examining their computers to maximize effectiveness and enhance quality. CSV SMEs will play a key role in achieving these advantages.
Our Pharma Educare CSV Course is based on 21 CFR and will be useful to individuals involved in conducting FDA inspections and Computer System Validation (CSV) on both a domestic and international scale or who are just about to enter the CSV field.
COMPUTERIZED SYSTEM VALIDATION (CSV) COURSE
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.
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.