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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

  • Logbook design

  • 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.

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