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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.
This course must be taught at a BioNetwork location.
Level: Beginner
Lecture Hours: 5.00
Lab Hours: 3.00
Total Contact Hours: 8.00
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
