Jim Christ travels the nation, helping DME’s with compliance, installing transfilling systems, training providers on everything oxygen… and has just about seen it all in his 18 years of experience. Here’s some of his most popular tips for getting the most from your oxygen business.
Formula For Success: Have a consistent approach in the structure and operation of your drug manufacturing facility. Having policies and procedures that all applicable employees can understand is essential when transfilling. All employees should be trained to follow these written procedures and understand what is expected of them. Setting up a consistent company structure can fortify the expectations that go along with being a drug manufacturer. Applied HHE can help any provider with their compliance.
First Steps: Once you have your formula for success don’t assume that everyone is doing everything that they are supposed to do. Regulatory agencies won’t. Have systems in place to 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 dividends at the time of an inspection because you’ll be prepared.
Branching Out: When the quality control system is in place you must continue to reinforce it with regular training of your employees. Not only is training required by regulatory agencies it will foster an attitude within your employees of being a stakeholder in the drug manufacture process.
Going Strong: With all your systems running like a well-oiled machine, don’t forget about the machines involved in the process. The equipment that is used in the drug manufacture does need periodic maintenance to ensure that they continue to run efficiently. Consult manufacturer guidelines for maintenance of your different pieces of equipment. There also might be improvements that you can make to your process to increase your efficiency.
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