BIOSC182 (or BIOSC882N): 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 2023, BIOSC182-2282 is an online course. Starts January 23. (The non-credit version, BIOSC882N-0948 is also online)

What happens in the course?

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

right to operate, warning letters, recall

What is regulated

cannabis, pharmaceutical, diagnostic testing, GMO’s

cannabis, pharmaceutical, diagnostic testing, GMO’s

Changes to regulations?

legislation, advocacy, critical thinking

Who are the authorities?

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

Why do the regulations exist?

history of legislation, enforcement, societal effects

What are the rules?

cGMP, SOP’s, Certificate of analysis, documentation

How do I know my medicine is safe?

Biopharmaceutical, Cannabis

How do we comply?

licensing, training, equipment, procedures, cGMP

How is compliance and safety checked?

audits, applications, documentation, facilities

How do I know my medicine is safe?

Biopharmaceutical, Cannabis

How is a new drug approved?

Canabis, pharmaceutical, etc.

How do I know my medicine is safe?

Diagnostic testing, Genetic testing

previous arrowprevious arrow
next arrownext arrow

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 Safety and efficacy of regulated products (GLP and cGMP, Principles and compliance) here.

Part of certificates

  • Biotechnology Technician
  • Biotechnology Associate of Science Degree
  • Biological Testing Technician (non credit certificate coming soon!)
Why take this course?
Safety and Efficacy Course