Good Lab Practices: FDA and EPA Regulations

This course may be taught at any location.

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Good Lab Practices: FDA and EPA Regulations
Level: Beginner
Lecture Hours: 5.00
Lab Hours: 3.00
Total Contact Hours: 8.00

Description

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.

Topics Include

The course is 8 hours, conducted in one 8-hour session and covers:

  • 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

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