Good Lab Practices: FDA and EPA Regulations

Good Lab Practices: FDA and EPA Regulations
850 Oval Drive
Raleigh, NC 27695

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
Instructor(s)
Gerald Picard
Class Dates
  • September 29, 2018
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
Building
BTEC
Room
124
Format
Face-to-Face
Course ID
197980