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Compliance4All webinars are just what professionals in the regulatory
compliance areas need for scaling up in their careers. With a collection of
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Compliance4All’s experts help you unravel all the knowledge you need…
Posted by Adam Fleaming on May 22, 2017 at 7:53am
A Claim Adjustment Reason Code (CARC) is a code used in medical billing to communicate a change or an adjustment in payment. CARCs have to be used to communicate why there was a difference between the amount paid in a claim or service line and the amount that was billed against it. CARCS are to be mentioned only if there is an adjustment of this kind. If there is no adjustment to a claim or…Continue
Posted by Roger Steven on May 19, 2017 at 8:44am
Diligence and a high degree of scrutiny are crucial for a person who is writing investigative reports in an organization. In the first place, an investigation has to be objective and not be vindictive. It should avoid targeting an employee personally; it should be thorough and proper from a legal perspective. When all the legal procedures are followed in an investigation, the case of the employer becomes strong and…Continue
Posted by kate smith on May 19, 2017 at 7:45am
Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and…
Posted by Adam Fleaming on May 19, 2017 at 6:17am
The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:
o Setting validation criteria and specifications
Posted by John Robinson on May 19, 2017 at 5:51am
Many organizations make the mistake of basing the suitability of candidates purely on their skills and the knowledge they bring. This measure goes only half the way, and is incomplete, because many organizations fail to take into consideration the fact that…Continue
Posted by kate smith on May 18, 2017 at 7:09am
There is no gainsaying the fact that bullying at the workplace is a very harsh and wicked way of degrading a colleague. It is a very uncivilized form of harassment at the workplace and is a serious deterrent to a healthy relationship at the professional level. Workplace bullying is very…Continue
Posted by kate smith on May 17, 2017 at 7:24am
One of the major fallouts of the passage of the Affordable Care Act (ACA) or Obamacare is the phenomenal rise in the number of physician practice acquisitions. These are some of the reasons for this rise:
- Because of physician practice acquisitions, healthcare providers can consolidate and integrate their business better, since acquisition brings about alignment between the business prospects of the referral networks with the hospital’s strategic goals
Posted by Roger Steven on May 17, 2017 at 7:00am
The knowledge of combination products and their regulations is essential for regulatory professionals. This is because of the high proportion of combination products in the market, as well as the array of regulations that govern them.
21 CFR 3.2 (e) has a complete definition of a combination product. A combination product is one…
Posted by Adam Fleaming on May 17, 2017 at 6:40am
Posted by John Robinson on May 17, 2017 at 5:56am