Good Lab Practices: FDA and EPA Regulations

Understand the documentation guidelines required to generate acceptable EPA and FDA product registration safety studies. In this course, you will undertake a series of exercises, including labeling activities, protocol review, and adherence to Standard Operating Procedures to reinforce course concepts.

Audience

This course equips professionals whose responsibilities depend on operating in CGMP facilities under FDA and EPA regulations:

Manufacturing Technicians
Team Leaders and Supervisors
Quality Control Personnel
Quality Assurance Personnel
Maintenance / Engineers

Topics Include

Introduction to SOPs
Following instructions in a SOP
Document control and report submission
Regulatory oversight

Learning Objectives

Demonstrate a broad understanding of EPA and FDA Good Laboratory Practice Guidelines in order to produce acceptable regulatory studies.
Understand the documentation guidelines required to generate acceptable EPA and FDA product registration safety studies.
Evaluate protocols, laboratory labels and SOPs