cGLP Compliance: Interpretation and Application

Course Description

This course will concentrate on the FDA's current interpretation of the GLPs (21 CFR Part 58) with an in-depth review of the agency's preamble, regulations, guidelines, inspection guides, compliance policy guides, publications and policy statements. Each section of the GLP regulations will be reviewed along with the FDA's interpretation of that section.

Special attention will be paid to the critical compliance aspects of gathering pre-clinical data in a regulated environment. An integral part of this course will include discussions on the FDA's interpretation and application of current GLP with a review of pertinent inspectional observations (FDA-483) and warning letters.

Course Outline

• Review of GLP Regulations, FDA Publications and Advisory Opinions
• Basic Techniques for GLP Interpretation
• GLP Interpretation by Subpart with FDA References
• Subpart A – General Provisions
• Subpart B – Organization & Personnel
• Subpart C – Facilities
• Subpart D – Equipment
• Subpart E – Testing Facility Operations
• Subpart F – Test & Control Articles
• Subpart G – Protocol
• Subpart J – Records/Reports
• Subpart K – Disqualification
• Review of FDA Inspectional Observations and Warning Letters
• Class Exercises on Practical Application and Interpretation of GLPs

Who Should Attend?

This course is valuable for personnel involved in pre-clinical studies.

• Pre-clinical study scientists/investigators
• Study directors and monitors
• Quality assurance and control personnel
• Compliance auditors
• Coordinators of multi-site projects
• Regulatory affair personnel