Course Offerings

This course provides a broad understanding of the requirements for conducting acceptable FDA and EPA studies. Lectures give an overview of Good Laboratory Practice Standards of the EPA (40 CFR Part 160 of the Federal Register) and FDA (21 CFR Part 58 of the Federal Register) for conducting acceptable regulatory laboratory studies in support of both pesticide and drug registrations. Class exercises will reinforce instruction in evaluation protocols, using SOPs for the preparation of standard solutions and the rejection of data, and the evaluation of laboratory labels.

Course Objectives

Receive an overview of the EPA and FDA Laboratory Practice Guidelines necessary to produce acceptable regulatory studies

Obtain an understanding of the documentation guidelines required for the generation of acceptable EPA and FDA product registration safety studies

Demonstrate practical experience with the evaluation of protocols, laboratory labels and SOP's through the use of hands-on exercises

Outline of instruction

Session 1
Module 1 - Introductions and definitions - 15 minutes
Module 2 - Personnel - 15 minutes
Module 3 - Testing facility - 15 minutes
Module 4 - Equipment - 15 minutes
Module 5 - Standard Operating Procedures - SOP's - 30 minutes
Lab SOP exercises - 60 minutes
Preparation of a calibration solution from a stock standard solution using and SOP 10.11.05 - label solution
Module 6 - Test, control, and reference substances - 30 minutes
Module 7 - Protocols - 30 minutes

Session 2
Module 8 - Good freezer stability protocol - 15 minutes
Bad protocol exercise - 30 minutes
Module 9 - Bad protocol evaluation and discussion - 15 minutes
Module 10 - Study conduct - 90 minutes
Principal investigator role example - typical data forms
Study director role play - rejection of data exercise using SOP ES.A.0601.01

Answers to rejection of data exercises
Quality assurance auditor role play - lab label exercise - evaluation of lab labels produced by instructor and class participants in preparation of solutions exercise in Module 5
Module 11 - Final reports - 15 minutes
Module 12- Archives - 15 minutes
Module 13 - EPA report of GLP Compliance Status in the US - 15 min

Contact Hours

8

CEUs

1

Industry Standard, State or National Certification

None

CE or CU Articulation

No

Prerequisites

None

Text and Supplies Needed

Provided

Clinical Site/Special Facilities

None

Requirements for Successful Completion

90% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

Specific Industry or Business Support Needs

N/A

Wake County Need for Industry Positions

N/A

Industry or Job Titles Related to training Outcomes for Employment

Related Courses

Course Contact Information

Bernita Nichols
919-335-1014
[email protected]