Discrete event simulation (DES) is the most powerful methodology used in process data analytics. The following examples will be covered: (i) Outpatient clinic: centralized or separate locations? (ii) Outpatient clinic: non-steady-state operations, (iii) Outpa ...
The session will provide an overview of the Federal Civil False Claims Act (FCA) and how it works. It will also provide an assessment of enforcement activities, showing how healthcare providers may be at risk. In addition, the session will review recent cases ...
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation w ...
The AKS is currently the focus of law enforcement officials. The Statute provides that the offer or payment, as well as the solicitation or receipt, of “any remuneration” in exchange for referrals of any good, facility, service, or item for which payment may b ...
Regulatory expectations are clear about manufactures’ responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standar ...
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies hav ...
During this webinar, we will go over the of fundamentals of CIP, CDD, EDD, CTR and also, current Issues that impact your day to day.
Due to an evolving climate with AML regulations, you need stay abreast of changes and the impact it has to you. Especially in a financial services industry where crime is rampant due to AML related activities. We will explore the recent changes, red flags and ...
During this webinar, we will review recent changes to the ACH rules and also discuss upcoming changes that might impact your organization or specifically, your role. Course Objectives: The foundation of ACH and Nacha Understand the rules created by Nacha ...
FDA, EU Notified Bodies, and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions. Organizations should provide evidence that they have the required means and abilities t ...