BIOSC182: Understand federal, state, and local regulations and how they can be applied to a variety of life science products such as cannabis, prescription drugs (pharmaceuticals), vaccines, tests for diseases, nutritional supplements, cosmetics, genetic testing and more.

Offered in Spring Semesters: for Spring 2022, BIOSC182-2282 is an online course. Starts January 24.

What happens in the course?

medicine leaf
medicine leaf
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What are the penalties for non-compliance?

right to operate, warning letters, recall

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What is regulated

cannabis, pharmaceutical, diagnostic testing, GMO's

cannabis, pharmaceutical, diagnostic testing, GMO's

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Changes to regulations?

legislation, advocacy, critical thinking

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Who are the authorities?

FDA, CA Dept of Cannabis control, USDA, EPA, DEA

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Why do the regulations exist?

history of legislation, enforcement, societal effects

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What are the rules?

cGMP, SOP's, Certificate of analysis, documentation

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How do I know my medicine is safe?

Biopharmaceutical, Cannabis

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How do we comply?

licensing, training, equipment, procedures, cGMP

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How is compliance and safety checked?

audits, applications, documentation, facilities

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How do I know my medicine is safe?

Biopharmaceutical, Cannabis

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How is a new drug approved?

Canabis, pharmaceutical, etc.

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How do I know my medicine is safe?

Diagnostic testing, Genetic testing

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Skills In

  • Good documentation practices
  • Standard Operating Procedures
  • cGMP (Good Manufacturing Practice)

Knowledge of

  • Importance of following established procedures
  • Inspections & Audits
  • Quality Assurance and Quality Control

Ability to

  • Comply with regulations and oversight in biological manufacturing
  • Product development and commercialization with cGMP and GLP
  • Validation: Equipment, Process, Computer, Analytical, Cleaning

Who should take this course?

  • Biotechnology careers
  • Cannabis industry

What types of jobs does it prepare for?

  • Workers in a regulated industry (cannabis, pharmaceutical, diagnostics)
  • Certified testing lab technician
  • Manufacturing technician
  • Food safety testing

More details about GLP and cGMP, Principles and Compliance (Safety and efficacy of regulated products) here.

Part of certificates

  • Biotechnology Technician
  • Biotechnology Associate of Science Degree
  • Biological Testing Technician (non credit certificate coming soon!)