Introduction to Computer System Validation Training (CSV01)
This one day course is designed for people who have recently joined a GMP-regulated environments within Life Science companies, for example;
- Quality Control personnel
- Operations or Manufacturing personnel
- Engineering personnel
As the Australian Code of Good Manufacturing Practice for Medicinal Products states;
“It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.”
Principle 1, Annex 15.
Learning Objectives and Course Description
Upon completion of this validation course participants will;
- Understand the importance of validation and why and how the information is collected and used
- Have an understanding of the V model and how it is used
- Validation Master Plans (VMP)
- User Requirements Specification, Functional Specification and Design Specification
- Design review / Design Qualification
- Installation Qualification, Operational Qualification, Performance Qualification
- Validation Summary Reports
- be able to perform validation testing
- have a rudimentary understanding of risk based validation
During this half day validation course participants will have the basic knowledge and appreciation of validation and debunk some of the myths associated with validation.
Benefits include
Trainees will:
- Learn from instructors who are actively involved in various validation studies across the life sciences industries
- Understand how to adopt sensible validation practices
- Receive a complete training kit, trainer’s notes and a certificate of completion for participants assessed.
View schedule and how to make a booking.
 |
 |
|
|
 |
