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Search Results For: fda audits
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...
It's FDA Renewal Time!
Are you confused about FDA registration? Dont be! Applied takes the worry out of annual registration for you! Transfillers need to annually renew their transfilling locations and drug listings with the FDA. Here are some quick...
Training by Personnel
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...
Applied Training FAQs
Who Needs Training and When? 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...
FDA Registration
Are you confused about FDA registration?DONT BE! Applied takes the worry out of annual registration for you! The FDA statesthat any firm that transfers oxygen from one container to another, via gas to gas, liquid to...
FDA Annual Records Review
If you received a letter from the FDA, and it said the following, would you know what it meant? Written procedures are not established for evaluations conducted at least annually to review records associated with a representative...
Need Required Training?
Are you and your employees meeting annual training requirements? The FDA requires that training be completed on a frequent and continuing basis. This has been interpreted to mean twice a year.This training must be completed...
Updated 2014 Applied Regional Seminars FAQ
...are providers keep up with changing regulatory and technical information. Applieds all new 2014 FDA, DOT, OSHA Accreditation Seminar covers everything you need to meet oxygen training requirements: 1. Oxygen Safety (Accre...
Are you confused about FDA registration? Applied can register for you!
Are you confused about FDA registration? Dont be! Applied takes the worry out of annual registration for you! The FDA says that any firm that transfers oxygen from one container to another, via gas to gas, liquid to gas, or...
Quick Tips - Label Requirements
...at Is Required? And By Who? Oxygen drug product labels are governed by 3 different agencies. The FDA because its a drug product, and the DOT and OSHA because it is considered a Hazardous Material that is in transport (DOT) a...
I Fill Oxygen
The FDA considers anyone who moves oxygen from one container to another to be an oxygen filler. That could be liquid to liquid, liquid to gas or gas to gas. The FDA requires manufacturers to follow cGMP (Current Good Manufacturing...
NEW OSHA Requirements For Oxygen Cylinder Labels
OSHA, FDA and DOT haveguidelines developed forprecautionary labels for use onoxygen cylinders and cryogenicvessels. These are to be used toidentify the contents, warning ofprincipal physical and healthhazards, and providing...
Oxygen Drug Product Label FAQ
...an oxygen drug product label? Oxygen drug product labels are governed by 3 different agencies. The FDA because its a drug product, and the DOT and OSHA because it is considered a Hazardous Material. Each agency is a differen...
Essential Training for Home Healthcare Providers
...en? Within 90 Days of Hire If you have a new hire, you will need DOT training within 90 days! The FDA (Food and Drug Administration) requires cGMP training, too, before you can let your new filler out on their own. Every 3 y...
About
... When delivering oxygen from point A to point B, safety is critical. All Applied products meet DOT, FDA, CGA and accreditation requirements for transporting oxygen cylinders and have you in mind. Smart features like lockable doo...
New FDA Drug Reporting Service
...is new service providesdrug manufacturers (transfillers) peace of mind knowing they are meeting the FDAs new requirement to report the amount of medical oxygen-filled and released to patients annually. The reported data will i...
Are you meeting required training?
Its Training Time! Who needs training and when? 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...
Links
FDA Drug Firm Annual Registration Status State Licensure Requirements Look Up your FDA Labeler and Product Code FDA Guidance Documents 2003 FDA Draft Guidance for Medical Gases 1989 FDA Guidance for Medical Gases Gas...
FDA Drug Reporting under the CARES Act
...ES Act mandates that all drug manufacturers report specific details about their drug volumes to the FDA. The FDA recently issued the final guidance for industry: Reporting Amount of Listed Drugs and Biological Products Under ...
UPDATE: FDA Drug Registration and Listing - Information Request
Recently, an email from the FDA was sent out in regards to drug listing requirements. The FDA has since retracted that email. In summary, if you have not changed what sizes of oxygen cylinders/liquid containers you fill since...
Oxygen Transfillers: Important Upcoming Deadlines You Need to Know
... transfillers and other drug manufacturers must annually report specific drug volume details to the FDA. This helps the FDA monitor drug manufacturing activities, preventing shortages and enhancing medical product oversight. W...
I am a QCU
...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 Audits Seminar Servomex 5200 (if have 5200) cGMP in...
An Overview of Applied Training Workbooks
...tion: Who Said So? and guide oxygen providers and transfillers through the Federal Law on cGMP. The FDA requires you to file certain information and follow current good manufacturing practice, as defined by the law and their ...
Events
FDA, DOT Accreditation Seminars 2022 This program has been approved for 5.75 contact hours(CRCE) credit by the American Association for Respiratory Care, 9425 N. MacArthur Blvd. Ste100 Irving TX 75063. Date Location Topic Type Wed,...
Get the training you need!
...ired. Within 90 days of hire If youve got a new hire, youll need DOT training within 90 days! The FDA requires cGMP training, too, before you can let your new filler out on his own. Every 3 years The US DOT requires that eve...
Resources
...u will find links to some useful information for Oxygen Providers Registration Search: Check your FDA Registration Status Here Search for your Labeler Code Here at the National Drug Code Directory FDA: The US Food and Dr...
2015 Medtrade Fall Show Preview and Show Specials
...Y magazine, with extra savings inside! Get all of your required training in ONE DAY with Applieds FDA/DOT Seminar! During our popular regional seminars you will learn the most current FDA/DOT requirements, oxygen safety, prope...
Filling parts and accessories approved by the FDA
The FDA requires certain filling parts and accessories to be approved for safety and identity. Do you know which filling parts and accessories must be FDA approved? See our list below: * Lot stickers are required by the FDA...
FDA Registration Made Easy!
It has been 6 years now since the FDA switched to electronic registration. Is it still a requirement to register every year? YES! In fact the FDA is still inspecting transfillers, and anecdotally we have seen an increase in inspections...
FDA Registration FAQs
Below is an FDA requirements cheat sheet with our frequently asked questions. If you are still confused, or looking for more answers, Applied can take the hassle away and register for you!Just give us a call for more information,...
Are you and your employees meeting required training?
Who? What? Where? When? The FDA requires that training be completed on a frequent and continuing basis. This has been interpreted to mean twice a year. This training must be completed by anyone who can affect the purity of the...
Maintaining Your Oxygen Equipment
3 Easy Steps toMaintaining Your Oxygen Equipment: FDA guidance requires that filling equipment be calibrated at specific intervals, depending on the type of equipment. Dont forget you need to document all calibration! 1....
Mini Oxygen Storage Audit
Are your cylinders stored according to state and FDA regulations? Oxygen cylinders must be stored properly in order to prevent contamination, keep unauthorized personnel away from cylinders, and to prevent them from being damaged...
Maintaining Your Oxygen Equipment: 3 Easy Steps
Maintaining Your Oxygen Equipment: 3 Easy Steps FDA guidance requires that filling equipment be calibrated at specific intervals, depending on the type of equipment. Dont forget you need to document all calibration! DAILY Each...
Servomex 5200 vs. Handheld Analyzers
...at gas. A Servomexs accuracy is (+ or -) 0.1% oxygen and has been validated by ORSAT apparatus to USFDA Pharmacopoeia 23. Oxygen is magnetic! Oxygen is attracted to a strong magnetic field most other gases are not. This para-mag...
Ensuring Compliance with Transfilling Regulations
...safety and efficiency. Understanding Transfilling Regulations The Food and Drug Administration (FDA) ) establishes strict guidelines for the transfilling of medical oxygen. These regulations cover various aspects, including equip...
I am a Filler
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...
Training Time!
...ining! Within 90 Days of hire If youve got a new hire, youll need DOT training within 90 days! FDA requires cGMP training, too, before you can let your new filler out on his own. Check out below for the training hell need. ...
Leak Testing: 101
FDA does NOT recommend using soap and water solutions to leak test oxygen cylinders. According to FDA guidance and industry standards, soap and water solutions used to leak test are not recommended and may even prove...
2015 Label Updates!
... the cylinder. Can I place these compliant labels on top of the ones under the clear coat? No. The FDA does not allow label stacking which is placing a label on top of a label. Youll need to have those cylinders replaced or ...
Choosing The Right Filling System
...y come back to us in a year or two to upgrade to the liquid to gas. How do I comply with all those FDA requirements? FDA requirements are simple.Essentially, you must register with the FDA annually (which we can do for you),...
Leak Testing 101: No Soap!
The FDA does not recommend using soap and water solutions to leak test oxygen cylinders. According to FDA guidance and industry standards, soap and water solutions to leak test are not recommended and may even prove dangerous. Soapcontains...
Editor Picks: American Made CPAP Tubing
Applieds medical tubing is made from materials that comply withFDAspecifications 21 CFR 177.1520 and 21 CFR 177.1210. All tubing is constructed from materials that comply with ISO 10993 / FDA standards for cytotoxicity and biocompatibility....
FDA requires 2 leak tests during the fill process
Leak Testing Notice from the FDA: According to FDA guidance and industry standards, soap and water solutions used to leak test are not recommended and may even prove dangerous. Soap contains animal fats ( lard ) which burns easily...
GHS Pictograms for Home Care Providers
OSHA, FDA and DOT haveguidelines developed forprecautionary labels for use onoxygen cylinders and cryogenicvessels. These are to be used toidentify the contents, warning ofprincipal physical and healthhazards, and providing appropriateprecautionary...
What Are Applied University Subscription Classes?
...ific Training) and Hazmat Security Training (for Hazmat Security Training). Subscription to Meet FDA Requirements Our Filling On Demand Subscription is designed to meet US Food and Drug Administration current good manufactu...
Quick Tips For Oxygen Cleaning!
...cedure youll have to follow for this is found in CGA G 4.1. What about leak testing? According to FDA guidance and industry standards, soap and water solutions used to leak test are not recommended and may even prove dangero...
Top Five Reasons You Should Consider Transfilling
...o compliance, regulatory or accreditation worries! Applied does it all! Wecan register you with the FDA, provide you with compliant labels, give you up to date documentation required by the FDA and train you! ...
Spring 2017 Medtrade Recap
... on the show floor, attendees were able to benefit from multiple educational conference sessions on audits, business operations, competitive bidding,executive education, legal guidelines for operating their businesses, Medicare...
The biggest problems with your oxygen supplier now solved
...o compliance, regulatory or accreditation worries! Applied does it all! Wecan register you with the FDA, provide you with compliant labels, give you up to date documentation required by the FDA and train you! ...
Upcoming FDA, DOT and Accreditation Seminars
Dont forget to sign up for our upcoming FDA, DOT Accreditation seminars. There are still quite a few left, and coming to a city near you! These full day seminars fufill training requirements for FDA, DOT and Accreditation for...
Equipment Calibration: Are you up-to-date?
...gnetic Analyzer | Calibrate Daily Paramagnetic oxygen analyzers are required by the FDAs current good manufacturing practices. Paramagnetic oxygen analyzers are different from handheld analyzers because they are...
Fime
.... La manguera para CPAP de Applied Home Healthcare Equipment es de materiales que cumplen con la FDA (especificaciones 21 CFR 177.1520 y 21 CFR 177.1210). Todas las mangueras se construyen de materiales que cumplen con las normas d...
Understanding Oxygen Cleaning
...esting Considerations Leak testing is another critical aspect of maintaining oxygen equipment. The FDA and industry standards recommend against using soap and water solutions for leak testing because these can leave behind r...
Servomex 5200 and Handheld Analyzers
...ity of that gas. A Servomexs accuracy is 0.1% Oxygen and has been validated by ORSAT apparatus to USFDA Pharmacopoeia 23. Oxygen is magnetic! Oxygen is attracted to a strong magnetic field most other gases are not. This para-magneti...
I am a Driver
... Respiratory Therapist, on up to a driver who has a CDL. Drivers need training as a requirement for FDA if they fill from a transfill system or if they fill liquid to liquid curbside. Oxygen Safety Oxygen 101 Online Class ...
FDA Bulletin: Brass and Viton Washers
FDA and NIOSH report that reusing single use washers, like nylon or plastic, can contribute to fires.Applied recommends using Brass and Vitonwashers when reusing washers. When used more than once, the Nylon crush gaskets require...
Are You Calibrated?
... equipment. Servomex Or Paramagnetic Analyzer Paramagnetic oxygen analyzers are required by the FDAs current good manufacturing practices. Paramagnetic oxygen analyzers are different from handheld analyzers because they are ...
Are you cleaning your cylinders according to FDA standards?
Are you cleaning your cylinders according to the FDA CFR Section 211.80 to Section 211.94? Drug product containers and closures play a critical role in assuring that the drug product provided to the patient has the appropriate...
Labels
FDA Drug Product Labels: PACKAGING and LABELING CONTROL Sections 211.122, 125, 130 A firm must establish written labeling procedures covering the receipt, identification, storage, handling and examination of all labeling. Procedures...
Train Your Team with Our Comprehensive Liquid to Gas Online Training
...the critical safety protocols that must be followed to prevent accidents and ensure compliance with FDA regulations. By training your new staff with this course, you can be confident that they will adhere to the highest safety s...
Applieds Live Regional Seminar FAQs
...iller, Is This Seminar For Me? Yes! The seminar covers accreditation and DOT requirements, and the FDA portion will help you understand your suppliers oxygen requirements better. How Long is the Seminar? The seminar runs f...
Visit Us At Medtrade Spring
...s and Marketing Executive Leadership Keeping it Legal Retail Strategic Planning Business Operations Audits and Compliance Medicare Updates Competitive Bidding Business Opportunity Networking and Special Events Be sure to stop ...
OxyCare Advantage
...e with competitive bidding, stringent documentation requirements, lower reimbursement, post-payment audits, tightening Medicare purse stringsMedicare fee-for-service should only be a component of the suppliers total income stream. There ...
Make Money In The DME Market
... last several years with reimbursement reductions, competitive bidding being implemented, increased audits and regulations by regulatory agencies, along with other factors such as nationwide recession. These factors have made it more ...
live-stream
LIVE STREAM: FDA, DOT and Accreditation Seminar Thanks for signing up for our live stream training with Jim Christ! A little about the instructor... James H. Christ is the National Sales Manager of Applied Home Healthcare Equipment,...
What is Your Sign? A Guide to Warehouse Signage
...erly and identified through proper signage. Medical oxygen is considered a prescription drug by the FDA and a hazardous material by the DOT. All companies that distribute oxygen must have signage to identify the various locati...
Make money despite competitive bidding
... last several years with reimbursement reductions, competitive bidding being implemented, increased audits and regulations by regulatory agencies, along with other factors such as a nationwide recession. These factors have mad...
Start Getting More From Your Oxygen Business
...heck that all of the requirements are being met when it comes to drugmanufacturing. Perform regular audits ofyour procedures, staff, and records orhave an outside agency do it for you.Doing a little work up front can pay major di...
I Deliver Oxygen
...urity Awareness, OF-113). We have over 30 different training options to keep you compliant with the FDA, DOT and accreditation agencies in 2013! 3. Any vehicle delivering oxygen or any other medical gas (in any amount) is re...
Six Ways to Serve Oxygen Patients Better and Increase Profits
...y and haz-mat charges, you should consider doing your own filling. Modern filling systems including FDA and accreditation requirements have made it easier, less costly, and more convenient than ever. You can often lease the entire sy...
A Quick Guide To Warehouse Signage
...erly and identified through proper signage. Medical oxygen is considered a prescription drug by the FDA and a hazardous material by the DOT. All companies that distribute oxygen must have signage to identify the various locat...
What is cGMP and why is it important?
...e of Terrys patients is severely injured from breathing oxygen contaminated with acetylene gas. The FDA is notified and with the aid of U. S. Marshals seizes Terrys patient records, oxygen cylinders, and pickup truck as evide...
Getting more from your oxygen business
...check that all of the requirements are being met when it comes to drug manufacture. Perform regular audits of your procedures, staff, and records or have an outside agency do it for you. Doing a little up front can pay major dividends at the...
Visit us at Medtrade
...ms! Free Giveaways and more! Come visit us at booth #621! Applied Medtrade Seminar: Our popular FDA, DOT Accreditation seminar will be held Monday, March 30th at the Luxor Hotel and Casino: 3900 Las Vegas Blvd South. Las Veg...
OxyCare Advantage Instant Patient Financing
.... With competitive bidding, stringent documentation requirements, lower reimbursement, post-payment audits, tightening Medicare purse stringsMedicare fee-for-service should only be a component of the suppliers total income stream. ...
OxySafe
...n safety devices on all oxygen concentrators and at the point of the patient. This is ISO 8359:1996 FDAM 1. You can read more about ISO 8359 here. Why did the ISO develop standard 8359 to require oxygen safety devices on oxygen...
What is a QCU?
The FDA requires each firm to establish a quality control unit (QCU). The QCU has the responsibility and authority to approve or reject all drug product containers, closures, in-process materials, labeling, written procedures,...
FDA, DOT Accreditation Training with Applied
We will be hosting Zoom live streams and in-person FDA, DOT seminars in 2024! Our popular full-day seminars cover everything you need to meet oxygen training requirements.Topics include how to handle, transport, and fill oxygen...
Team
...n tank? Any equipment? email us attech@applied-inc.com Regulatory Questions: Need more info about FDA, DOT and accreditation? email us atregistration@applied-inc.com Training: Need help with training your employees? email...
Handy Calibration Chart From Applied
FDA guidance requires that filling equipment be calibrated at specific intervals, depending on the type of equipment.Dont forget you need to document all calibration! Equipment should have annual calibration according to NIST...
What is OxySafe?
...n safety devices on all oxygen concentrators and at the point of the patient. This is ISO 8359:1996 FDAM 1. You can read more about ISO 8359 here. Why did the ISO develop standard 8359 to require oxygen safety devices on ox...
Warehouse Signage
...ification 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 to mark different stora...
OxyCare Total Advantage PLUS
...e with competitive bidding, stringent documentation requirements, lower reimbursement, post-payment audits, tightening Medicare purse stringsMedicare fee-for-service should only be a component of the suppliers total income st...
FAQs
...ed to be reliable and is based on technical information and experience currently available from the FDA, DOT, industry associations and others.However,Applied Home Healthcare Equipment and its affiliates make no guarantee of t...
Cylinder Requalification Policy Update
...ta5or10yearinterval. All cylinders must be inspected with appropriate Food and Drug Administration (FDA) cGMPs, applicable with the Compressed Gas Association (CGA) pamphlet and meet all DOT requirements. WHATS CHANGING? T...
Start Getting MORE from Your Oxygen Business
...double check that every requirement is being met when it comes to drug manufacture. Perform regular audits of your procedures, staff, and records or have an outside agency do it for you. Doing a little up front can pay major div...
Help
...n tank? Any equipment? email us attech@applied-inc.com Regulatory Questions: Need more info about FDA, DOT and accreditation? email us atregistration@applied-inc.com Training: Need help with training your employees? email...
Applied University FAQs
...de range of topics that will get you all of the required training you need to meet requirements for FDA, DOT, OSHA and Accreditation. When and where can I take Applied University classes? Applied University online classes ca...
For Immediate Release Competitive Bidding, Round 2
...or 12 VDC outlet in a car. POC patients never run out of oxygen. POCs eliminate the cost of DOT, FDA, and all safety risks associated with high pressure or cryogenic oxygen. Plus, there is no need for costly maintenance and pe...
Demystifying Oxygen Filling: Gas to Gas
...s to gas systems are wall mounted, so they have a small foot print. Youll need to register with the FDA, and do some training, which most reputable manufacturers provide in their system packages. Is a Gas to Gas System Right ...
Medtrade Fall Preview 2016
...ed training completed in one day the day before the show opens. Applied will be hosting its popular FDA/DOT Accreditation seminar at the Omni Hotel from 9am-3pm. Its not too late to sign up! Click here to learn more or give us a ...
Best Plastic Valve Seals
The FDA and accreditation require you to use valve seals on your filled cylinders to protect against contamination. Fillers love OxyLok plastic valve seals because they slide easily over the post valve and lock in place. Patients...
Medtrade Fall 2014
...onday, October 20, 2014 (Day Before Medtrade) Full day seminar to fulfill training requirements for FDA, DOT and Accreditation for oxygen fillers and providers! Click here for details and to sign up! To view our latest issue...
OxySafe2™ Fire Safety
...ave beentaken, including thermal fuses designed to act as firebreaks in oxygen tubing. OxySafe2, an FDA-listed thermal fuse, demonstratesthe potential to decrease HOT-related fires when installed at critical points in the oxyg...
Is your Servomex analyzer calibrated correctly?
...rated each fill day with a specialty calibration gas that has a COA like our calibration gases. The FDA does not allow USP oxygen to be used to calibrate analyzers. (i.e. you cant use the oxygen you get to fill your tanks to cali...
What Cleaner Should I Use For My DME?
...Look For.... Testing for Leaks The use of an approved leak detecting solution is required by CGA, FDA, DOT, Health Canada, ISO, accreditation agencies, and many others for general and patient safety. Allowing medical gas leaks...
Applied University
All of the online training you need to maintain compliance with the FDA and DOT throughout the year is available through our brand new Applied University portal! All of our individual on-demand classes and subscriptions can now...
FDA Drug Reporting for Transfillers
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FDA Registration Update
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FDA Drug Reporting for Manufacturers (Transfillers)
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