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Chemical and Biomedical Regulations and Lab Methods (CHEM 2320)
Total Credits:
4
Lecture Credits:
2.5
Lab Credits:
1.5
Description:
This course will address the federal regulations and global, ethical, and environmental considerations of bioscience products. You will learn to participate as a responsible stakeholder by following Food and Drug Administration and Environmental Protection Agency regulations. You will gain an understanding of current Good Manufacturing Practices, Quality Control (QC), Good Laboratory Practices, Good Clinical Practices and current Good Tissue Practices. You will apply notions of civic responsibility through study of international regulations, global perspectives, intellectual property laws, and import/export considerations. Laboratory sessions will provide hands-on experience in QC procedures, scientific measurements and safety regulations. You will learn to prepare reagents and solutions; adopt aseptic techniques, sterilization procedures, and clean-room procedures; and use various instruments. You will practice critical documentation aspects and learn about standard operating procedures. Must be taken A-F.
Topical Outline:
1. Why are products regulated, expectations of a consumer/society; difference between “worker safety” and “product safety”, safety regulatory agencies (OSHA, EPA, DOT, NRC) and standards organizations
2. Federal Register, and Code of Federal Regulations, structure and organization of FDA, what does each office oversee; other regulatory and standards agencies (national and international)
3. Stages in product development, approval application processes in pharma, medical devices, biologics; current Good Manufacturing Practices (cGMPs); QSR, Quality Assurance (QA) and Quality Control (QC), GLPs, and GCP
4. Intellectual Property (Patents, Trade Marks, Trade Secrets, Copyrights, Geographical Indications, Traditional Knowledge, Creative Commons)- significance in academic research and industry innovations
5. Laboratory activities on safety, documentation, good record-keeping, Raw materials certification, quarantine of chemicals, Mathematical calculations in reagent preparation, solutions preparation and testing accuracy, pipetting techniques, Water quality
6. Metrology, IQ, OQ, PQ of laboratory equipment and measuring devices, user logs and SOPs, handling and maintenance of basic laboratory instrumentation, Clean-Room requirements, cleanroom apparel; Aseptic techniques, Sterilization of labware and reagents
Learning Outcomes:
1. Describe the roles of FDA and its different divisions, USDA and EPA in regulations of consumer products, roles of safety and environmental regulatory agencies. Navigate FDA’s CFR database, and understand the importance of international agencies
2. Identify employee responsibilities in producing quality work and demonstrate knowledge of stages of product development, regulatory approval processes for medical devices, pharma, biologics, food products, aspects of cGMP, QA, QC, QSR, GLP and GCP
3. Apply good lab practices and documentation in a laboratory including protocols, standard operating procedures, legal scientific notebook, logbooks, batch-records, labels and inventories; how to write them, follow them and maintain them
4. Verify raw materials as per specifications and learn how to carry out laboratory procedures with minimum sources of error as per quality systems, conduct Math calculations and lab procedures associated with preparation of laboratory reagents
5. Be able to use and maintain various equipment, manage the labs for raw materials, resources, water quality testing and equipment, inventories, appropriate process of cleanrooms usage, cleaning of glassware and sterilization of materials
6. Use Chemical fume hoods and biological safety cabinets, know the classification, Autoclaves usage, sterile filtrations, aseptic techniques, Cryogenics sample storage, chemical ordering, Environmental considerations in product handling and safe disposal
Prerequisites:
CHEM 1151