How to Transition to an FDA Compliant Facility


Many general manufacturing facilities in the future will need to transition to a cleanroom manufacturing plant due to the fact that the goods they manufacture like electronic cigarette liquids and certain food goods may come under FDA regulations soon. This course will explore how to turn your current manufacturing facility into a cleanroom regulated by the FDA. Information on building requirements that you will need to update; protocol for workflow changes; and monitoring equipment and protocol upgrades will be discussed.

Course outline     Who should attend?     Course materials     Instructor     Next dates and location  




Course outline
  • Understanding the importance and operations of FDA monitoring practices
    • Updates in FDA monitoring include more manufacturers (types)
    • Effective dates of compliance with the FDA (new industries and projected inclusions)
    • Non-conformance issues, penalties, shut downs by FDA - what you can expect.
  • How to upgrade Facilities to FDA compliance
    • Building requirements to update from clean manufacturing to monitored FDA compliant cleanroom
      • Comply with FDA minimum standards for cleanroom structure
        • Types of walls, flooring and coverings
        • Cleanbuild requirements
        • Certifications necessary for startup/operation
      • Filter and airflow requirements
        • Filter coverage & type requirements
        • Velocity guidelines
        • Equipment placement for airflow requirements
        • Air pressurization requirements
      • Air pressurization requirements
  • Alternative options for modular cleanroom
    • Softwall
    • Hardwall
    • Air filtration unit/filters for modular cleanrooms
  • Protocol, gowning and workflow requirements
    • Type of gowning / PPE required
    • Protocol on where to store stock gowning apparel and materials
    • Workflow within the facility
  • Cleaning
    • Mandatory cleaning materials, chemical and applicators
    • Typical cleaning process requirements
    • Intervals/ Frequency required
  • Testing and Reporting Examples in compliance with FDA
    • Type of tests / certifications necessary to stay in compliance
    • Frequency of tests to monitor the cleanroom environment
    • Problem solving issues during an excursion event
Who should attend?

Information coming soon.

Course materials

  • Copy of PowerPoint presentation in course binder
  • Certificate of attendance for completion of CEUs

Continuing Education Units: .6 CEUs

Instructor
Jason Roth


Next dates and locations

No dates are currently scheduled.