Latest News

Month: September 2013

Who needs training?

By Kristen Cifranic
September 25, 2013 Category: General

In any manufacturing operation involving human manipulation there are hazards which may be created by preoccupation, mental lapse, carelessness and the like. Therefore, all on-the-job and CGMP training should be revisited at frequent intervals and needs to be conducted by qualified individuals. A firm is expected to establish detailed written procedures (training program) outlining the specific areas of the firms operation to be covered. On-the-job training is acceptable, as long as the training is conducted by a qualified individual on a frequent basis. Any employee involved in the manufacturing, filling, processing, handling, holding, or shipping of a medical drug is required to be trained both on-the-job and in the current good manufacturing practices. This would include all delivery and/or truck drivers who deliver medical drug products. The lack of CGMP training is one of the most overlooked areas observed at most medical gas firms. CGMP training should be conducted by qualified

Its in the Bag! Patient Cylinder Bags

By Victoria Marquard-Schultz
September 23, 2013 Category: Equipment, Business

Review of Patient oxygen cylinder bags for M6 cylinders, D and and Helios liquid portable unit bags.

How to Stop Patient Cannula Fires

By Victoria Marquard-Schultz
September 23, 2013 Category: Oxygen Safety, Oxygen, Equipment

How OxySafe Firebreak stops a patient oxygen cannula fire. OxySafe is the same device as a FireSafe.

Training Time!

By Victoria Marquard-Schultz
September 23, 2013 Category: Training Education, Regulatory Compliance

When oxygen providers need training for their employees, what training and how often.

New GHS Oxygen Label and Training Requirements from OSHA

By Victoria Marquard-Schultz
September 20, 2013 Category: Training Education, Regulatory Compliance, Equipment

New GHS Oxygen Label and Training Requirements from OSHA

Are You Calibrated?

By Victoria Marquard-Schultz
September 20, 2013 Category: Equipment, Regulatory Compliance

FDA requirements for calibrating and maintaining transfilling equipment.

What Cleaner Should I Use For My DME?

By Victoria Marquard-Schultz
September 18, 2013 Category: General

What Cleaner to Use for Oxygen Durable Medical Equipment and Medical Oxygen Cylinders

What is a QCU?

By Kristen Cifranic
September 18, 2013 Category: Regulatory Compliance

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, the authority to review production records to assure completeness and accuracy, and is responsible for the approval or rejection of all manufactured drug products. The responsibilities and procedures applicable to the QCU must be in writing and must be followed. The designated person(s) are required to meet the Personnel Qualification requirements [211.25], must be identified in the firms procedures, and must receive appropriate quality assurance training. This includes training in the particular operations that the employee performs and in current good manufacturing practice as it relates to the employees functions. A small firm may designate a single individual with the personnel qualifications. QCU managers and personnel can get the training they need fast

Getting more from your oxygen business

By Jim Christ
September 12, 2013 Category: Oxygen, Equipment, Training Education, Business

Tips, tricks and details on filling your own oxygen, and doing better in the oxygen transfilling business

What is cGMP and why is it important?

By Kristen Cifranic
September 05, 2013 Category: Oxygen, Regulatory Compliance

Learn what cCMP means and why it is important when you are an Oxygen Provider.

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