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May 05, 2024
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2022-2023 Catalog [ARCHIVED CATALOG]
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BIOT 105 - Survey of Regulatory Affairs
PREREQUISITES: Program Chair’s Approval
PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 3
DATE OF LAST REVISION: Summer, 2011
This course provides an entry level introduction to the laws and regulations that govern the development, marketing and commercial distribution of drugs, biological and medical device products and how they relate to the pharmaceutical, biotechnology and medical device industry. This course is intended to provide individuals with a greater understanding of regulatory affairs, specifically providing an understanding of how their actions are controlled by regulations and how to interact with FDA or global regulatory agencies.
MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course the student will be expected to:
- Demonstrate the ability to understand the biomanufacturing drug process.
- Demonstrate awareness of the medical device process and various reporting compliance.
- Locate information students might need in their role as a regulatory professional.
- Demonstrate the ability to understand and discuss Biotechnology and Medical Device Industries guidance and regulations.
- Identify and be able to describe global U.S. drug and device regulations.
- Demonstrate the ability to differentiate the product life cycles including preclinical, clinical, and marketing regulatory processes.
- Identify and understand the role of regulatory agencies and the regulatory affairs professional.
- Demonstrate the ability to understand the Drug/Biologics and Medical Device Process and Risk Management.
- Demonstrate the skills of good documentation.
- Demonstrate the ability to understand the purpose, outcomes, goals and regulatory processes regarding internal audits and FDA audits.
- Interpret proposed regulations and guidance and locate the resources that provide updates approval process.
COURSE CONTENT: Topical areas of study include -
- Regulatory Agencies and Compliance (FDA, TGA, MHLW, EU, Health Canada)
- Current Good Clinical Practices (cGCP)
- Standard Operating Procedures (SOP)
- Code of Federal Regulations (CFR) Title 21
- Federal Food Drug and Cosmetic Act (FDCA)
- ISO
- Annual Reporting and Regulatory Compliance
- The Federal Register
Course Addendum - Syllabus (Click to expand)
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