BTEC 1300: Introduction to Regulations and Quality

Program Description:

The Biotechnology program at Salt Lake Community College (SLCC) prepares students for transferring to higher education and employment in the biotech industry. SLCC offers a Biotechnology Associate of Science degree and a Certificate of Proficiency. Classes are offered in a competency-based education format. Curriculum outlines for the program and materials for additional courses are available to view separately. 

Course Description

This course provides "an introduction to a regulated manufacturing environment" for biotechnology products and how manufacturing is overseen by the Food and Drug Administration. The course explores the production of and regulations for medical devices, pharmaceuticals, and dietary supplements. The contents are divided into eight modules. Module one explores regulations and medical devices. Topics range from medical device manufacturing in Utah to medical device classification. Module two considers quality system regulations and the quality management system. The module introduces learners to said concepts and goes into further detail on design controls, corrective and preventative actions, and more. Module three highlights document controls and types. Information on accessing this content and documentation practices are highlighted alongside other topics. Module four explores the manufacturing environment. Here, students are introduced to the lab and complete a performance assessment. Module five covers the manufacturing of DNA extraction kits. Module six introduces learners to lean manufacturing and waste. Waste solutions are provided. Module seven educates on the Kaizen and PDCA cycle. A performance assessment follows this module. Finally, module eight presents standard work documents and how to apply them to the manufacturing process. As a hybrid course, students completed lecture modules online and lab activities on-campus.

Contents Description

Course materials include a course curriculum outline, syllabus, and a Canvas .imscc file. The 3-page syllabus includes a brief description about the course, primary learning objectives, information about grading, course policies, and campus resources. The 3-page course curriculum outline includes a rationale for action, course description, course learning outcomes, and course outcomes mapped to SLCC college-wide learning outcomes.

The .imscc file contains numerous folders and files from the Canvas course. Below is the list of modules and their contents.

• Orientation Module
  • Welcome
  • Get to Know Your Course
  • Learning and Technical Support
  • Netiquette
  • Introduce Yourself
  • Any Questions? (optional)
  • Announcements
• Module 1: Regulations and Medical Devices
  • A Regulated Industry
  • Medical Device Manufacturing in Utah
  • What is the Food and Drug Administration?
  • Food, Drug, and Cosmetic Act
  • Sulfanilamide
  • Thalidomide
  • Laws
  • Regulations
  • Guidance Documents
  • Title 21 of the Code of Federal Regulations
  • What is a Medical Device?
  • Medical Device Classification
  • Class I Medical Devices
  • Class II Medical Devices
  • Class III devices
  • The International Organization of Standardization
  • FDA Inspections
  • Interacting with the FDA
  • Preventing Tragedy
• Module 2: Quality System Regulations and the Quality Management System
  • Quality System Regulations
  • 21 CFR 820
  • Quality Management System
  • Seven Subsystems
  • Management
  • Design Controls
  • Production and Process Controls
  • Corrective and Preventative Actions
  • Equipment and Facility Controls
  • Records, Documents, and Change Controls
  • Material Controls
  • What Can Happen Without Quality Management
• Module 3: Document Controls and Document Types
  • Quality Management in STUDENTfacturED
  • Documentation in STUDENTfacturED
  • Document controls in STUDENTfacturED
  • STUDENTfacturED Document Management
  • Accessing BTEC 1300 SharePoint site
  • Good Documentation Practices
  • STUDENTfacturED Part numbers
  • Applying Good Documentation Practices
  • Why does GDP matter
• Module 4: The Manufacturing Environment
  • Introduction to the STUDENTfacturED Lab
  • Safety and quality
  • Welcome to the lab
  • Filtering SharePoint
  • Performance assessment - Safety and lab organization
• Module 5: DNA Extraction Kits
  • Introduction to manufacturing
  • Manufacturing Cheek Cell DNA Extraction Kits
  • Collecting documents for manufacturing
  • Following a Work Instruction Document
  • Filling in a Batch record form
  • Manufacturing Following a WID
• Module 6: Lean Manufacturing and Waste
  • Introduction to lean manufacturing
  • What is lean manufacturing
  • What is Waste
  • How do we identify waste
  • Eliminating Waste
• Module 7: Kaizen and the PDCA Cycle
  • Kaizen
  • How does Kaizen work
  • Kaizen Cards
  • PDCA cycle
  • PLAN
  • DO
  • CHECK
  • ACT
  • Other Lean tools
  • Performance assessment - PDCA Cycle
• Module 8: Standard Work Documents
  • Standard Work
  • Applying Standard Work to the Manufacturing Process