“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.”
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“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.”
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“With regulations often spanning hundreds of pages, how can compliance teams efficiently manage the process without missing critical details?”
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“Any discussion or plan that doesn’t take into account whether or not you can actually execute on it is an exercise in fantasy.”
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“Healthcare compliance professionals face significant challenges when managing who is responsible for completing compliance activities. From identifying the right individuals to ensuring accountability and avoiding duplication, the process can be fraught with inefficiencies.”
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“Managing priorities, like juggling chainsaws, requires not just courage, but a deep respect for the risks and rewards involved in each decision.”
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“Still, it’s possible for smaller healthcare systems to compete. To do so, you need to ask yourself two questions – who are you and what are you measuring?”
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“Compliance work is complex, and success in compliance requires human interaction. By understanding the psychological and organizational factors influencing decision-making, you can create work product (e.g., policies, training) that empowers employees to consistently make better operational decisions and foster a stronger culture of compliance.”
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“The first thing that you should understand is this: you don’t have to build the perfect program. Your education program just needs to be good enough to ensure employees have the training needed to demonstrate core knowledge and pass audits and inspections.”
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