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HIPAA survival is one of the great challenges for a healthcare entity. HIPAA audits are complex, and they need understanding of the jargon and the semantics of the words mentioned in the document to survive. Both the Covered Entity and the Business Associate need…Continue
Posted by John Robinson on January 17, 2017 at 4:32am
Stay interviews are not done at the time of recruitment, nor are they exit interviews. A stay interview is done while the employee is working in the organization and has not quit, but shows signs of doing so. This is the defining feature of stay interviews.
As opposed to job interviews and exit interviews; stay interviews are interviews done by organizations to evaluate the level of satisfaction an employee is facing at work in the organization while she is still working…Continue
Posted by kate smith on January 17, 2017 at 3:50am
Differences between GMP and GLP are important to understand for professionals who work in areas which involve these two different, yet related practices. Since the two appear somewhat similar in terms of their application and nomenclature; there is considerable scope for misunderstanding and confusion.
It is necessary to understand the nature of the differences between GMP and…
Posted by John Robinson on January 16, 2017 at 5:53am
Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices…Continue
Posted by John Robinson on January 16, 2017 at 5:46am
Handling Supplemental Pay under the FLSA is an essential knowledge for HR and Finance professionals alike. This is because supplemental pay is a major area that, if handled incorrectly, can land the organization in court. The federal rules relating to supplemental pay are contained in Title 29, Part 778 of the Code of Federal Regulations and enforced by the Wage and Hour Division of the U.S. Department of Labor (DoL).
An understanding of what supplemental pay is becomes…Continue
Posted by kate smith on January 16, 2017 at 5:13am
That emotional intelligence enhances productivity at the workplace is a paradigm most organizations have understood. Because of this, training employees in emotional intelligence for increasing performance is now becoming the aim of many organizations. Emotional intelligence is a great tool for changing…Continue
Posted by kate smith on January 13, 2017 at 6:14am
How to implement 21 CFR Part 11, the regulatory guideline which deals with compliance for electronic records and signatures, is a challenge for professionals in the medical devices and pharmaceutical industries. The FDA has set out 21 CFR Part 11 to help the regulated industries that come under its purview to structure their business processes…
Posted by John Robinson on January 13, 2017 at 5:17am
ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.
ISO 14971 and IEC 62304:2006 are global…Continue
Posted by John Robinson on January 13, 2017 at 4:30am
Artificial Intelligence (AI) as a tool of education has unimaginably high potential. Artificial Intelligence as a discipline, at least in the form and shape we have come to associate it with, has come a long way from its inception a few decades ago. In the simplest terms, AI is the intelligence used by machines to perform predesignated tasks. From the earliest times, when in its rudimentary form, it was used to make machines carry out mechanical tasks, it is now used to power…Continue
Posted by kate smith on January 12, 2017 at 6:36am
Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing…Continue
Posted by John Robinson on January 12, 2017 at 4:51am