BIOT 103 - Safety & Regulatory Compliance

or Program Chair Approval.
PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 3
DATE OF LAST REVISION: Fall 2023

Overview of laboratory safety procedures and precautions, biosafety, radiation safety, compliance standards of regulatory agencies. Emphasis will be placed on understanding the regulatory environment of pharmaceutical, diagnostic and agricultural research and manufacturing. Students will be introduced to the agencies in the U. S. responsible for regulatory oversight of biotechnology. Concepts of current good laboratory practices (cGLP), current good manufacturing practices (cGMP), standard operating procedures (SOP) and validation will be addressed as they apply to industry. This course will include an online OSHA 10 hour certification program in which successful completion results in students earning their OSHA 10 General Industry certification.

MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course the student will be expected to:

1. Demonstrate the ability to follow laboratory safety procedures and precautions through hands-on lab activities.
2. Demonstrate awareness of risks associated with a biotechnology laboratory and be able to create a chemical hygiene plan for that laboratory.
3. Know how a laboratory should be prepared for emergency situations.
4. Identify and be able to safely handle, store and dispose of hazardous, biological, and chemical and radioactive materials.
5. Identify and be able to use personal protective equipment (PPE) under the appropriate conditions.
6. Follow the appropriate safety procedures and guidelines with reference to physical hazards in the laboratory.
7. Identify and understand the role of regulatory agencies for which compliance is important in biotechnology.
8. Develop an understanding of the scientific basis for regulatory compliance in biotechnology.
9. Demonstrate the ability to understand and follow written technical instructions.
10. Demonstrate the skills of good documentation.
11. Interpret and follow GXPs and SOPs and locate the resources that provide updates.
12. Identify and understand validation methods as they apply to biotechnology.
13. Research and analyze intellectual property and its impact on biotechnology.
14. Assess readiness to take OSHA 10 Hour General Industry Certification exam.

• Regulatory Agencies and Compliance (FDA, USDA, EPA, OSHA, ISO)
• Current Good Laboratory Practices (cGLP)
• Current Good Manufacturing Practices (cGMP)
• Current Good Clinical Practices (cGCP)
• Current Good Environmental Practices (cGEP)
• Standard Operating Procedures (SOP)
• Laboratory Safety
• Material Safety Data Sheets
• Protective Equipment
• Handling, Storage, Disposal of Laboratory Materials
• Maintenance and Validation of Laboratory Equipment