Training by Personnel

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Training by Personnel

Feb 12, 2014

The FDA requires training on a "frequent and continuing basis", usually interpreted to be about twice a year. The Quality Control Unit, and all Oxygen Transfilling Personnel should have proper FDA training for their jobs. Drivers need training as a requirement for FDA if they fill from a transfill system or if they fill liquid to liquid curbside. The DOT requires drivers to have training "at least every 3 years, and within 90 days of employment for new employees". See the list below for all training options:

QCU: The QCU, or the Quality Control Unit is the person or person(s) responsible for ensuring that the drug product is safe and high quality. They ultimately reject or accept all parts of the manufacturing process as meeting quality expectations. The QCU should have FDA training twice a year and should take at least one of each of the following classes:

Oxygen Safety

Oxygen 101 Online Class

FDA cGMP Training

Filling 101 Online Class

Liquid 101 Online Class

FDA Audits Seminar

Servomex 5200 (if have 5200)

cGMP in Plain English: A Guide to Federal Law Workbook, OF-1600

Gas to Gas Oxygen DVD Training Course, OF-1550

Liquid to Gas Oxygen DVD Training Course, OF-1500

Haz-Mat Security Awareness

Haz-Mat Security Awareness Online Seminar

Quality Training

QCU 101, OF-201

Delivery Training

Delivery 101

Liquid 101

DOT in Plain English: A Guide to Federal Law Workbook, OF-1290

Alternatively, the Quality Control Unit could:
Attend our Regional Seminar to get everything in one day!
OR
get access to all of our online classes for Fillers with the Filling On-Demand Subscription (OF-5000F), plus take Quality 101 and FDA Audits.

Oxygen Transfilling Personnel: The FDA considers anyone who moves oxygen from one container to another to be an oxygen transfiller. This could be personnel that uses a liquid to gas or gas to gas system or someone who fills a home unit- either at the facility or from the back of the vehicle.

Oxygen Safety

Oxygen 101 Online Class

FDA cGMP Training

Filling 101 Online Class

Liquid 101 Online Class

Servomex 5200 Online Class

cGMP in Plain English: A Guide to Federal Law Workbook, OF-1600

Gas to Gas Oxygen DVD Training Course, OF-1550

Liquid to Gas DVD Training Course, OF-1500

Alternatively, Oxygen Transfilling Personnel could:
Attend our Regional Seminar to get everything in one day!
OR
get access to all of our online classes for Fillers with the FIlling On-Demand Subscription (OF-5000F).

Delivery Driver: Delivery Drivers are ANYONE who delivers even just one cylinder of oxygen. This could be a Respiratory Therapist, on up to a driver who has a CDL.

Oxygen Safety

Oxygen 101 Online Class

FDA cGMP Training

Liquid 101 Online Class

Delivery Training

Delivery 101

Liquid 101

DOT in Plain English: A Guide to Federal Law Workbook, OF-1290

Haz-Mat Security Awareness

Haz-Mat Security Awareness Online Seminar

Alternatively, the Delivery Driver could:
Attend our Regional Seminar to get everything in one day!
OR
get access to all of our online classes for Drivers with the Delivery On-Demand Subscription (OF-5000D).

General Personnel: Anyone who handles or comes into contact with oxygen should be properly trained in oxygen safety to ensure the safety of the employees and patients. Additionally, personnel that take this training can serve as back-ups to sign the batch production record.

Oxygen Safety

Oxygen 101 Online Class

Batch Product Records Training

Batch Production Records 101