Equipment Logbooks: Good Practices and Regulatory Requirements
This eLearning module covers the regulatory expectations and practice related to equipment logbooks.
Importance and requirements of logbooks
Regulatory expectations related to logbook and activities to be recorded
Regulatory requirements for complaints and recall handling
Management and upkeep of logbooks
Data entry in logbooks
Review of logbooks
US FDA 483s related to logbooks
Logbook- Do’s & Don'ts
Why it matters
All major GMP guidelines including US FDA\, EU GMP and Schedule M have clear requirements on logbook usage and recording of events. While proper recording can support data integrity in many ways\, Improper use and event recording can lead to regulatory observations and warning letters. Adoption of simple processes in this module can save hassle and improve the organization’s GMP compliance.
Who is it for
This course covers fundamental GMP requirements related to documentation and is for all employees involved in GMP and supporting operations.