GXP Solutions | Good Laboratory Practices (GLP) Training

Good Laboratory Practice (GLP) Training

This GLP training course provides essential information about nonclinical study regulations. This training is developed as an interpretation of the FDA 21 CFR Part 58 regulations. The course is divided into two (2) options with the following scope:

Note

Course content can be tailored to your business needs.

All courses are live group or webinar training events only.

Course 1 – Good Laboratory Practice (GLP) Regulations

Good Laboratory Practice (GLP) regulations cover the following topics.

Introduction
Module 1: History of GLPs
Module 2: Subpart A: General Provisions
Module 3: Subpart B: Organization and Personnel
Module 4: Subpart C: Facilities
Module 5: Subpart D: Equipment and Computer Systems
Module 6: Subpart E (Part 1): Test Facility Operations – SOPs and Reagents/Solutions
Module 7: Subpart E (Part 2): Test Facility Operations – Animal Care
Module 8: Subpart F: Test and Control Articles
Module 9: Subpart G (Part 1): Protocols for Nonclinical Studies
Module 10: Subpart G (Part 2): Conduct of a Nonclinical Study
Module 11: Subpart J: Records and Reports

Course 2 – Good Laboratory Practices (GLP) Auditing Course

Good Laboratory Practice (GLP) Auditing Course. Topics may include:

Standard operating procedures (SOPs)
Study conduct
Review of Study-specific documentation and data
Test and control article characterization and handling (e.g., Storage container labeling)
Test and control article mixtures with carriers
Reagents
Test facility management
Study director responsibilities
Study personnel
Quality assurance unit
Final study report (including contributing scientist reports)
Archival of study records
Facility/equipment
Animal care
Electronic data capture systems