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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.
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
Portability
This course must be taught at a BioNetwork location.
Level: Beginner
Lecture HoursLab HoursTotal
Instructor Pool
Gerald Picard
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