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This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for ...
This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and ...
One of the major requirements of the health care organization to be HIPAA compliant is to develop and implement a set of HIPAA privacy and security policies and procedures. This can be a daunting task for those not knowing where to start and what a set of HIP ...
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 ...
A disaster recovery plan – also known as a business continuation plan – is designed to provide a set of policies and procedures for what to do in the event of a major business interruption event. This topic addresses what the health care organization needs to ...
Waiting lines in healthcare are everywhere. Queuing theory is one of the widely used tools of Data Analytics/Operations Research. It is a quantitative approach to the analysis of the properties of waiting lines (queues) when patients’ arrival (demand for servi ...
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...
This webinar will investigate the ethical and social challenges stemming from computing and telecommunication technology, as well as from mobile information-enabling devices. The goals are to provide attendees with background in Cyber Ethics and the analytica ...
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 ...
LGBTQIA+ workers still go to work every day for fear that they might lose their jobs because of who they love and who they are. There is no federal law protecting the LGBTQIA community from workplace discrimination and harassment. There is confusion among org ...