Request this Course
Submit this form to request this course to be scheduled.
This course gives an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements. Also covered are major areas subject to regulatory inspections and audit by the FDA and other international agencies. Samples of assessment tools are provided.
This course may be taught at any location.
Submit this form to request this course to be scheduled.
This 1 day, 8 hour course covers the following topics:
Upon successful completion, participants will be able to:
This course is designed for individuals seeking an understanding of computer system validations and/or professionals in the biotechnology industry with experience in Production and/or Quality Management seeking to apply these concepts at work.