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Equipment Logbooks: Good Practices and Regulatory Requirements

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 improve the organization’s overall GMP compliance. ​ This course covers fundamental GMP requirements related to documentation and is one of the fundamental GMP training for everyone involved in GMP and supporting operations like R & D and process development. ​


₹199.00

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Course Overview

90+ Hours Training

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 

Course Curriculum

1 Subject

Equipment Logbooks: Regulatory Expectations and Practice

1 Learning Materials

Course Content

Equipment Logbooks

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FREE

Section 1

Section 2