Curriculum
Course Description:
This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements of computer system validation and data integrity.
Upon completion of this course, you will be able to:
- Understand the data integrity regulatory requirements
- Explain the ALCOA+ principles
- Understand the computer system validation process including policies and procedures, roles and responsibilities, training, supplier management, planning and continuous improvement
Applies to the following audiences:
- Manufacturing organizations
- GMP auditors and trainers
- Regulatory professionals and Inspectors
- Students in pharmacy related degrees