21 CFR Part 58: GLP for Nonclinical Laboratories

This course on Good Laboratory Practices (GLP) equips nonclinical lab professionals with essential knowledge for 21 CFR Part 58 compliance, covering history, purpose, personnel responsibilities, animal care, equipment maintenance, facility operations, and record-keeping.

Who should enroll?

This course is ideal for professionals involved in nonclinical laboratory studies, including laboratory technicians and quality assurance personnel. It’s also beneficial for those in pharmaceuticals, biotechnology, and medical devices who seek to ensure their operations meet GLP standards.

Topics outlined in the course:

• Introduction to the significance and history of Good Laboratory Practices (GLP)
• Detailed exploration of 21 CFR Part 58 GLP regulations
• Understanding the organization and personnel roles in GLP compliance
• Insights into the facilities, equipment, and operations involved in nonclinical labs
• Thorough examination of test and control articles and their handling
• Guidelines for maintaining records, reporting, and dealing with disqualification of testing facilities

This certified course provides a thorough exploration of 21 CFR Part 58, detailing critical concepts in Good Laboratory Practices (GLP) through an engaging, interactive platform. Each module is enhanced with case studies and quizzes to ensure a deep and practical understanding. Upon successful completion, participants will be awarded an internationally recognized GXP training certificate, accredited with CPD/CEU credits.

Curriculum:

Introduction

Lesson 1: Why is GLP Important in NonClinical Laboratories

Lesson 2: Overview of GLP Regulation (21 CFR Part 58)

Lesson 3: General Provisions and Organization and Personnel

Lesson 4: Facilities

Lesson 5: Equipment and Testing Facilities Operation

Lesson 6: Test and Control Articles

Lesson 7: Protocol for and Conduct of a Nonclinical Laboratory Study

Lesson 8: Records and Reports

Lesson 9: Disqualification and Testing Facilities

Conclusion

Final Assessment