Editor’s Note: This column can serve as a companion article for the Consultant’s Roundtable on page 14.

Admin – CGMP Training – Online Training Resources

Food and Medical Gas – CGMP Training for Administrative Personnel

Visit research.net/r/QuizforGMPTrainingforAdministrativePersonnel 

  • 11-minute video presentation
  • The essential FDA regulations for administrative personnel
  • Essential GMP regulations
  • Lot number tracking
  • Complaint procedures
  • Quiz
  • Certificate of participation

Food Gas – Online Training Resources

Food Gas – Qualified Facilities and Submitting the FDA Attestation

Visit bit.ly/2T2CTGF to view the Food Gas Roundtable recording discussing the FDA Qualified Facility exemption and how to submit the Attestation.

  • 15-minute video presentation
  • The FDA regulations (21 CFR 1175(a) and 21 CFR 117.201)
  • Describe the Qualified Facility exemptions
  • Detail the two sales criteria for a Qualified Facility
  • Alternate Qualified Facility requirements and meaning of the Attestation
  • The Attestation
  • Where to get the form
  • Who must submit?
  • Submission schedule
  • How to fill out the form

Food Gas – CGMP Training for Pumpers

Visit www.research.net/r/FoodCGMPTrainingforPumpers 

  • 28-minute video presentation
  • The FDA regulations (21 CFR 117)
  • Allergen training
  • Sanitation training
  • Quiz
  • Certificate of participation

Food Gas – For Owners and Managers

This video for food/beverage gas company owners and managers discusses how to set up a compliant food/beverage gas program. Here is the URL to the 62 minute video and other food gas resources:
www.asteriskllc.com/foodbeverage-gas-resources 

Medical Gas – Online Training Resources

Medical Gas – CGMP Training for Pumpers

Visit www.research.net/r/MedicalGasOperatorCGMPTraining 

  • 25-minute video presentation
  • The FDA regulations (21 CFR 211)
  • Quiz
  • Certificate of participation

Medical Gas – CGMP Training for Drivers

Visit www.research.net/r/CGMPtrainingformedicalgasdrivers 

  • 23-minute video presentation
  • The FDA regulations (21 CFR 211) pertaining to medical gas container deliveries
  • Recognizing medical gas labels
  • Medical gas tamper-proof connections
  • Quiz
  • Certificate of participation
  • These are the automated programs we built for training food, beverage and medical personnel. If you need the programs in other formats, just let me know.
  • CGA – Online Training Resources

FREE e-Learning Resources from CGA

These, and other, high-quality e-Learning modules are available to GAWDA members who participate in the FREE GAWDA/CGA Safety Program. See: www.gawda.org/resources/cga-subscription-program/.

You can access these, and other, programs at portal.cganet.com/Publication/Index.aspx. Then filter by “Video & Training Materials.”

  • TM-4  Filling of Uninsulated Carbon Dioxide Cylinders
  • TM-5  Filling of High-Pressure Medical Oxygen Cylinders
  • GAWDA University – Online Training Resources
  • GAWDA U is FREE to GAWDA MEMBERS!

GAWDA University Online is an employee training curriculum and management tracking protocol that addresses many of your training needs in the areas of compliance with safety practices and government regulations, which are impacting your core business. Get more information at: www.gawda.org/gawda-university/.

Course samples:

  • cGMP Training Part 1: An Introduction to the FDA
  • cGMP Training Part 2: Definitions and Prohibited Acts
  • cGMP Training Part 3: Overview of cGMPs per 21 CFR
  • FDA CGMPs for Clerical/Counter Positions
  • Nitrous Oxide Facts & Guidelines
  • Quality at a GAWDA Company   
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GAWDA’s FDA and Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk, LLC in Lewisville, TX. Members can reach him at 508-883-0927 and tom@asteriskllc.com.

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