Assessment-based prediction is the basis to good candidate hiring

Hiring is among the most important activities for an organization, because it is the process by which the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up their mind by asking critical questions with […]

Verification vs validation is a key understanding for regulatory professionals

For regulatory professionals, aspects of verification and validation, such as how to get verification and validation right, and an understanding of the ways in which verification and validation diverge from each other and converge, make up very important learning. The key point is that verification and validation should be risk based and be built keeping […]

Get your HIPAA compliance right in six simple steps

The most important element that Covered Entities and Business Associates must keep in mind while carrying out HIPAA audits is best summarized in the words of Jocelyn Samuels, the top Federal official in charge of HIPAA enforcement. To quote her own words, Covered Entities and Business Associates must ensure compliance through “… a comprehensive and […]

Application of concepts and theories of clinical research

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed. […]

Handle internal investigations thoroughly, else employees could approach law agencies

Employees have a right to approach external sources such as the Equal Employment Opportunity Commission (EEOC), the National Labor Relations Board (NLRB), Wage and Hour, private attorneys, and juries against the employers, when feel that their legitimate complaints are not being heard by their employers. But first, a clear definition has to be made of […]

Maximizing profits and patient outcomes during times of dwindling reimbursements

Shrinking professional services reimbursements from all insurance companies is a fact that all practices are facing. With patient footfalls falling and operating costs skyrocketing; there is a need for everyone to look at ways by which to generate additional revenue opportunities with their existing patient base and at the same time, maximize patient clinical outcomes. […]

Medical products need to be validated for Radiation Sterilization

Do it right the first time” should be the mantra for medical device manufacturers that plan to make radiation products. Choosing the most functional and radiation resistant materials for their medical device will help them avoid the trouble of going through the post launch cycle of product revisions. To get this right, one simple line […]

Ensuring compliance with healthcare laws is of utmost importance for healthcare providers

Compliance with the many laws, as well as implementation of the necessary compliance initiatives are the means by which healthcare providers and entities or organizations involved in any type of healthcare transaction, especially those who bill or are involved with services payable by a CMS program, play a part in the protection of the integrity […]

Cleaning validation should have a policy designed to meet harsh regulatory requirements and principles

Compliance with the required cleaning validation regulatory compliance guidelines set out by the regulatory authorities such as the FDA, WHO, PIC/S and EU is essential for those who work in facilities which involve cleaning. The reason for which adherence to these regulatory guidelines is necessary is that these cleaning procedures need to establish and demonstrate […]

Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). There are three types of Premarket Notification 510(K)’s that may be submitted […]