21 CFR Part 11
Our Consultants have been heavily involved with ISPE GAMP® initiatives on Part 11 and the evolving regulatory interpretation. We therefore have a good insight into the regulatory requirements necessary for Computerised Systems to meet compliance with the ruling, and we have significant experience of helping our clients achieve compliance.
This practical GAMP® based course explains the ruling and the very latest interpretation and guidance material. This will help your staff get a better insight into how to determine which records are within the scope of the ruling, how to apply a records risk based approach, how to manage and analyze your records, define requirements, conduct assessments and help mitigate any risks or gaps in system processes or functionality.
