Training by Personnel
...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 ... Applied Training FAQs
...ts have over 50 years of compressed gas experience.
How Can I Get Training?
Applied offers online classes, live seminars, traditional training workbooks and tools for in house trainers.
How Often Do I Need Training?
FDA requires ... Applied University FAQs
What is an Applied University online class?
Applied University hosts a variety of online training classes. Our on-demand options are pre-recorded classes that can be viewed at any time, from any location! Both options have a... What Are Applied University Subscription Classes?
Applied offers two types of online classes: one time access for one student and subscription classes that offer unlimited access for unlimited students for 12 months. As a general rule, if you need to train more than 2 people,... Need Required Training?
...ccreditation Seminar
Live stream (online)
*Dates and locations subject to change.
On-Demand Classes Subscriptions
Agency?
When?
Who?
What Training?
FDA
on a frequent and continuing basis. This has been ... Updated 2014 Applied Regional Seminars FAQ
...uring:
All 3 FDA Guidances, DOT interpretations for Homecare Providers, Samples of Shipping Papers, Batch Production Logs, Label Inventory Logs and real warning letters from the FDA to Homecare providers.
How it Works
Our expe... Applied University
... year is available through our brand new Applied University portal! All of our individual on-demand classes and subscriptions can now be accessed from the same easy-to-navigate website.
Simply purchase the class or subscriptio... FDA Annual Records Review
...valuations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
No? Dont worry, let us translate. This excerpt is from an actual 483 letter (a list of obs... I am a QCU
... as meeting quality expectations. The QCU should take at least one of each of the following type of classes:
Oxygen Safety
Oxygen 101 Online Class
FDA cGMP Training
Filling 101 Online Class
Liquid 101 Online Class
FDA... I am a Filler
...ntinuing basis, usually interpreted to be about twice per year.
Oxygen Safety
Oxygen 101 Online Class
FDA cGMP Training
Filling 101 Online Class
Liquid 101 Online Class
Servomex 5200 Online Class
cGMP in Plain Engl... Filling parts and accessories approved by the FDA
...rs because they create a higher level of durability and safety when used in oxygen atmospheres.
* Batch Production Records are one of the three types of written documents that a transfiller needs to keep. These records need... Lot Stickers 101
...equired to be assigned a new lot number.
The assigning of a single lot number for an entire days production is not acceptable, you must do so by batch. A manufacturing operation, such as the filling of high pressure cylinders... Lots 101
...s required to be assigned a new lot number.
The assigning of a single lot number for an entire day production is not acceptable, you must do so by batch.A manufacturing operation, such as the filling of high pressure cylinder... How Technology Can Enhance Growth at Home and at Work
...n-board battery. It had to be plugged into a wall outlet to power up and use. However, it was still classified as a portable computer because it could be hand-carried.
The Osborne 1 shipped with a large bundle of software w... I am a Driver
...m a transfill system or if they fill liquid to liquid curbside.
Oxygen Safety
Oxygen 101 Online Class
FDA cGMP Training
Liquid 101 Online Class
Delivery Training
Delivery 101
Liquid 101
DOT in Plain English: A Gui... Applieds Live Regional Seminar FAQs
...afternoon break. Instruction usually finishes around 3pm, and the final exam is given and graded in class.
What Do I Do About Lunch?
Lunch is provided! Lunch break is typically from 12-1 and is catered.
Can I Teach Others ... Applied University Walkthrough
...versity online courses now have a handy YouTube guide to give you a virtual tour for accessing your classes. The Applied University Walkthrough video will show you:
a step-by-step guide for accessing your classes
actual sc... Cylinder Handling After a Natural Disaster
...plier.
Cylinders collected from natural disaster areas must be separated according to their hazard class. Oxidizing and flammable gases should be kept at least 25 ft apart. The cylinder label provides information on its contents... Training Time!
...quent and continuing basis and be documented. A popular option for a variety of training are online classes in cGMP and our FDA Filling on Demand Online Course Certifications (or get the classes a la carte if you only have a few... Are you correctly using lot stickers?
...quired to be assigned a unique lot number.
The assigning of a single lot number for an entire days production is not acceptable. A manufacturing operation, such as the filling of high pressure cylinders on a multi-outlet mani... Shipping Papers: Do you have them and do you use the new 2013 format?
...iption in 49 CFR 172.202(a). That order is: Identification Number, UN Number, Shipping Name, Hazard Class, and Packing Group.
Essentially, in comparison to the old way of writing shipping papers, the UN Number must be listed first, ... Labels
... to assure that the correct label is used on the drug product, including the identification of each batch with a lot number.
All high pressure cylinders, large cryogenic vessels and cryogenic home vessels are required to bear an adequ... What is a QCU?
...t containers, closures, in-process materials, labeling, written procedures, the authority to review production records to assure completeness and accuracy, and is responsible for the approval or rejection of all manufactured dru... Are you meeting required training?
...quent and continuing basis and be documented. A popular option for a variety of training are online classes in cGMP and our FDA Filling On-Demand Online Course Certifications.
# OF-5000F: Filling On-Demand Subcription
Unl... Oxygen EXPO2 2021
...industry.
The 2021Oxygen EXPO2 virtual eventwill be held from January 26th thru January 28th, 2021.Class sessions will run for approximately 1 hour with a short QA session at the conclusion of the class.
The Oxygen EXPO2 will p... An Important Message Regarding COVID-19
...locations will remain open to manufacture, ship and service product at this time.
We have increased production and can ship OxyGo product same day.
All OxyGo units are cleaned and disinfected prior to shipment, including warranty... OxySafe2™ Fire Safety
... oxygen significantly increases the flammability of materials, causing more intense fires and rapid production of dangerous fumes.
Around 16 million Americans have been diagnosed with Chronic Obstructive Lung Disease (COPD), ... GHS Pictograms for Home Care Providers
...the gas to ensure that the labelcomplies with applicable governmentregulations.
When a chemical is classified according to the GHS hazard criteria adopted in OSHAs hazard communication (HazCom) standard, the corresponding pictogram must appear on ... What is the DOT Rule on Carts and Racks?
...ny amount of oxygen. (This jurisdiction is found in 49 CFR 171.1)
The DOT dictates that all gases (class 2 materials) when transported be securely restrained in an upright or horizontal position, loaded in racks or packed in boxes or ... 2015 Label Updates!
... oxygen labels?
OSHA has adopted a set of standards known as GHS, or Globally Harmonized System of Classification of Labeling of Chemicals. GHS created a universal system of standardized pictograms and the hazards associated ... Get the training you need!
...quent and continuing basis and be documented. A popular option for a variety of training are online classes in cGMP and our FDA Filling On-Demand Online Course Certifications.
# OF-5000F: Filling On-Demand Subscription
Unlimite... Warehouse Signage
Proper storage and identification of medical oxygen isessential. Medical oxygen is classified as a prescription drug by the FDA and a hazardous material by the DOT.
Companies handling oxygen distribution are required to use signage... FDA Registration Renewal for Transfillers: What You Need to Know
Understanding FDA Registration
If youre involved in the production or distribution of medical oxygen, you likely know that staying compliant with FDA regulations is crucial. One key requirement is the FDA registration and annual... Essential Training for Home Healthcare Providers
...quent and continuing basis and be documented. A popular option for a variety of training are online classes in cGMP and our FDA Filling On-Demand Online Course Certifications.
End-of-Year Training Opportunities
Last Two Liv... Fall Fire Safety Tips for Oxygen Users and Those Working with Oxygen
...e all the difference. Remember, never attempt to extinguish a fire caused by oxygen with wateruse a Class B or C fire extinguisher instead.
Stay Safe This Fall
By following these fire safety tips, you can enjoy the beauty... Visit Us At Medtrade Spring
... his competition.
While booth sales have reportedly remained brisk for Medtrade 2018, there is one class of exhibitors that has not been asked back. York Schwab, Account Executive for the show, said earlier this year, We are no... DOT Law for Home Medical Oxygen
...al of Trade Exception (49 CFR 173.6): Shipping papers are not required if the hazardous material is classified as a Material of Trade, which typically applies to smaller quantities for personal or business use.
What Must ... Medical Oxygen and No Smoking Signs
...n them. However, DOT states that there should be no smoking within 25 feet of a vehicle loaded with class 5 hazardous materials, which oxygen qualifies. Its recommended to post No Smoking signs inside and outside of these delive... Who needs training?
...* of the type, time, and attendance of each session.
Applied offers CGMP training books and online classes to help get you compliant for the year. Click here to find out what training you need.
*All training must be documen... Emergency Preparedness for Providers
There are many situations that can be classified as emergencies such as fire, severe weather situations, and incidents with people.Being prepared for situations like these is crucial for responding effectively.
For all emergency... About
...you succeed.
With Applied youll have access to compliance programs, including:
Regional training classes that are driven by the latest compliance information you need, including seminars on oxygen safety, FDA requirements, DOT... News
... this will continue. In fact, new preventative maintenance, general maintenance, and related online classes will soon be offered augmenting Applieds on-site equipment.
Will Applied Be Making or Supplying Andonian Cryogenics ... My Employees Need Training
...om Applied come with the Curriculum Vitae (CV) of the trainer who wrote the workbook or teaches the class in the video. The CV should be kept with personnel training records to show that the trainer is qualified.
... Oxygen Drug Product Label FAQ
...pdate my labels?
OSHA has adopted a set of standards known as GHS, or Globally Harmonized System of Classification of Labeling of Chemicals. GHS created a universal system of standardized pictograms and the hazards associated... NEW OSHA Requirements For Oxygen Cylinder Labels
...ory agency.
OSHA: The Newest Changes
OSHA has adopted GHS.GHS, or Globally Harmonized System of Classification of Labeling of Chemicals, is a system used world wide to standardize the labeling and safety data sheets (SDS) ... What is cGMP and why is it important?
...irreversible health consequences.
Learn all about cGMP and other requirements with Applieds online classes from Applied University.
... New Labeling and Hazcom Training Requirements
GHS, or Globally Harmonized System of Classification of Labeling of Chemicals, is a system used world wide to standardize the labeling and safety data sheets for chemicals. Because there are so many chemicals and hazardous... New GHS Oxygen Label and Training Requirements from OSHA
GHS, or Globally Harmonized System of Classification of Labeling of Chemicals, is a system used world wide tostandardized the labeling and safety data sheets for chemicals. Because there are so many chemicals and hazardous...
If it has been 30 days or less since you received your item, please reach out to us for an RMA (Return Material Authorization). Some items may require a restocking fee, and some special-order items and medical devices may not be eligible for return. Click here to view our full return policy.
Subscribe to our Newsletter
Get the latest regulatory info, accreditation news and exclusive discounts!