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“Being a healthcare compliance professional involves navigating a complex landscape where law, risk, operations, ethics and patient care intersect. These professionals play critical roles in preventing reputational and financial risks that could jeopardize their organization and its ability to serve patients effectively.”
There have been many times where we have talked to auditors or inspectors who wanted to know if training occurred. While the answer was yes, there also have been times where we didn’t have any concrete documentation to support it, save for the Outlook meeting invite with everyone’s name on it. Even more surprisingly, there have been times where that has been accepted. Now, call it chance, dumb luck, or we dodged a bullet, but this is not always the case.
As compliance officers, we spend a lot of time focused on how others perform their jobs. However, being self-aware of how we do our own
“Audit readiness in quality is no different than anything else – follow a pre-defined process to the letter, tweak it as necessary and continue to evolve it until it works for your organization. It’s not hard. People just panic because the auditor can shut them down. But you wouldn’t panic if you had a process to follow to minimize the damage.”
“The U.S. opioid epidemic holds important lessons for compliance professionals. This public health crisis is characterized by the widespread misuse of opioid drugs, leading to addiction, overdose deaths and a profound social and economic toll.
This epidemic has evolved over the past few decades, and while there are many contributing factors, the role of pharmaceutical companies, particularly in the early stages, is widely seen as a critical element.”
“With regulations often spanning hundreds of pages, how can compliance teams efficiently manage the process without missing critical details?”