Good Lab Practices: FDA and EPA Regulations

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
Good Lab Practices: FDA and EPA Regulations
Class Dates
  • March 25, 2017
Class Days & Times
  • Sat - 8:00 AM to 5:00 PM
Class Level
Beginner
Lecture Hours
5.00
Lab Hours
3.00
Total Contact Hours
8.00
Building
BTEC
Room
124
Format
Face-to-Face
Course ID
170223