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     Registration




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


November 15, 2017
1821 Walden Office Square, Suite 370
Schaumburg, Illinois 60173

Save $120 off your registration by registering no later than September 1. Use coupon code SS1117FDA.


Registration information

Buy 3 Get 1 Free! Register three attendees from your company for the same training course and receive a complimentary fourth registration for another person in your company to attend that course. Contact IEST at 847-981-0100 to arrange this option. (Complimentary registration applies to registration of equal or lesser value. Not valid with any other offers or promotions.)

Registration Fees Regular

Member
Non-member

$715
$815


  • All registrations are transferable to another person for the same event but are not refundable. Notification of transfer must be made at least seven days prior to the event. Transfer fees apply. Exception: IEST reserves the right to cancel courses, in which case registrants will receive a full refund of the tuition fee.
  • Program and instructor(s) are subject to change.
  • All registrations include morning and afternoon breaks and lunch. Includes certificate of attendance, and .6 CEUs.
  • Payment must accompany registration; there is no invoicing. IEST does not accept purchase orders as a method of payment.
  • All member dues must be current at the time of registration to qualify for the member rates.
  • All education training courses earn Continuing Education Units.
  • International attendees: Full International Attendee details.

Download the print registration form.

Warning: Commercial, for-profit training companies have sprung up that are using the same course titles and promotional text as in IEST courses. Please be aware that IEST does not support, approve, provide any recognition of, or expertise to such courses. IEST does not assume any liability for the material presented in such courses. Registrations for IEST courses are only available through the IEST website.