BIOSC182: This course will introduce students to the concepts of quality control, safety, efficiacy and validation as it relates to manufacturing in regulated industries. GLP, cGMP, Quality Assurance and Quality Control laws, regulations, and quality practices associated with life science industries are included. Examples of applications in the biotechnology, cannabis, pharmaceutical, agriculture, food and medical device industries are included.

Skills In

  • Good documentation practices
  • Competency in terminology and acronyms applicable to the topic of regulation in biotechnology
  • GLP (Good laboratory practices)
  • cGMP (current Good manufacturing practice)
  • Practice of writing SOP’s (includes steps, procedures products, standards, objectives, formats, development procedures, review processes, implementation, evaluation)
  • Interpret sample FDA citations

Knowledge of

  • Quality Assurance and Quality Control (functions and concept)
  • Role of government oversight in development and manufacturing, including applicable federal, state, local and industry regulations
  • Development of a new biotechnology product, from research and development through various phases of testing to gaining FDA approval, and the regulations that pertain to each phase
  • Inspection and verification of the quality of a product
  • Importance of following established procedures
  • Importance of corrective action and preventive action in continuous improvement
  • Key validation concepts including equipment, process, computer, analytical and cleaning validation
  • Rationale of writing SOP (Standard Operating Procedure)
  • Inspections & Audits
  • GCP (Good clinical practice)

Ability to

  • History of Regulation
  • Role of government oversight in development and manufacturing, including applicable federal, state, local and industry regulations
  • Product development and commercialization as related to GMP, GLP, GCP
  • Validation: Equipment, Process, Computer, Analytical, Cleaning
  • Environmental Health & Safety
  • Investigations
  • SPC (Statistical Process Control) & Continuous Monitoring
  • International oversight regulations and their application

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

Core Competencies

  • Recognize when information is ncecssary and respond to appropriate personnel (Manage and Communicate information)
  • Errors in technical documents noted, reported, and changes suggested (Manage and Communicate information)
  • Quality process at EVERY LEVEL is a requirement of the law – even en food processing with the lowest level employee (why are you puttimg this particular label on this particular package?)
  • Work in manner expected by regulatory structure (Manage and Communicate information)
  • Label detail must be perfect
  • The Right to Operate is based on Quality systems and Regulatory compliance
  • Follow SOP’s and processes exactly. Carefully do each step in order. Know exactly how results of one protocol flows into the next.
  • SOP sign off means EVERYONE is responsible
  • Inefficiencies are recognized/continuous improment occurs (Manage and Communicate information)
  • Integrity and honesty. (overcome fear of negative news – mistake, etc. – accountability) (be forthright)
  • Good documentation standards (Manage and Communicate information)
  • Quality management systems – Auditors as a way of testing QA skills.
  • Presentations (Manage and Communicate information)
  • Speak-up culture, critical thinking (ID when wrong and have courage to spek up
  • Items labeled appropriately and trackable (Manage and Communicate information)
  • Communication with supervisor or casual client question. What are you doing (this technique), and why are you doing it? Why is what you are doing important? (technical sense of the ‘care’ of the step, and Information gained by the technique for the project)
  • Keeping the lab certified – – Overall GOOD QUALITY of work is the key
  • Practical exercise in critical thinking: build case for having opition. Build Examples for situational question during interview.

Course outline of record for complete information. BIOSC182 COR