Title: BTEC-1300-301-302-303-F21

Orientation Module Template
  Welcome
  Get to Know Your Course
  Learning and Technical Support
  Netiquette
  Introduce Yourself
  Any Questions? (optional)
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 for Standardization
  FDA Inspections
  Interacting with the FDA
  Preventing Tragedy
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 Preventive Actions
  Equipment and Facility Controls
  Records, Documents, and Change Controls
  Material Controls
  What Can Happen Without Quality Management
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
  Practicing GDP
  STUDENTfacturED Part numbers
  Applying Good Documentation Practices
  Why does GDP matter
The Manufacturing Environment
  Introduction to the STDUENTfacturED lab
  Safety and quality
  Welcome to the lab
  Filtering SharePoint
  Performance assessment - Safety and lab organization
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
Lean Manufacturing and Waste
  Introduction to lean manufacturing
  What is lean manufacturing
  What is Waste
  How do we identify waste
  Eliminating Waste
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
Standard Work Documents
  Standard Work
  Applying Standard Work to the Manufacturing Process