The ongoing Part 11 inspection and enforcement program is the mechanism by which the FDA continues to enforce implementation of Part 11. Using this method, this regulatory agency has, in just the last four years, issued more than 30 Warning Letters for deviations from Part 11. The most important reasons for which citations get issued by the FDA relate to insufficient integrity, security and availability of electronic records, as well as validation of software and computer…
Added by Adam Fleming on September 30, 2016 at 6:56am — No Comments
Identity theft is the biggest and fastest growing crime in the world. Children, elder and even dead can have their identities stolen because it is easy to perpetrate and easy to get away with. An identity thieves can steal identity from computer, smartphone, laptop and iPod through modern technology.
Everyone is vulnerable to identity theft because even if you are doing everything right, the companies or institutions with…Continue
Added by Michael Zhou on September 29, 2016 at 8:56am — No Comments
The fact that between five and eight percent of current recall and shipment rejection issues happen within the cold chain food transportation sector, resulting in fairly high, but preventable financial loss is an indication of how much scope is there to contain seepage in the food and transportation industries.
Is this happening because of lack of regulation? No. Rather, it is…
Added by Adam Fleming on September 29, 2016 at 5:59am — No Comments
It is absolutely necessary for all laboratory personnel to be aware of the current compliance issues and the ways of preventing FDA 483 and Warning Letter observations. To do so, they must:
o Be proactively alert
o Identify problem areas, and
o Implement corrective actions in order to prevent regulatory actions.
How do laboratories make this happen? Are there specific methods and procedures that they must keep in mind that will help them be…
Added by Adam Fleming on September 28, 2016 at 6:15am — No Comments
Health and safety training can be crucial in the workplace, even for industries that are deemed ‘safe’. With so much training and advice on offer, it is important to choose the correct provider for your business. You will save time and…Continue
Added by Alex on September 27, 2016 at 8:35am — No Comments
The Electronic Health Record (EHR) license agreement is the core document for physician practices that have just entered the EHR arena, as well as for practices that transition to a new EHR software package.
The license agreement should ideally state and clear issues such as:
Added by Roger Steven on September 27, 2016 at 7:22am — No Comments
By their nature, clinical trials are at times large complex projects that take years to complete. They involve many different resources, and are covered by extensive federal regulations. Regulations have been enacted with the purpose of documenting the efficacy…Continue
Added by Roger Steven on September 26, 2016 at 7:47am — No Comments
The Internal Revenue Service (IRS) has a high priority task of identifying as many employees as it possibly can. This is done to assess social security, Medicare and unemployment taxes, which will help the government to earn revenues. During the course of this action, should the IRS locate a red flag, it will initiate an audit.
It is always good for the employee to take steps to prevent being audited. Further, she should know how to handle an audit…
Added by Adam Fleming on September 26, 2016 at 7:28am — No Comments
A Cyber Security Incident Response Program (CSIRP) or a Cyber Security Incident Response Team (CSIRT) that anticipates and neutralizes a cyber-incident is a critical need for organizations, because an Internet or network security breach results in loss of valuable data, as well as several resources and the organization’s reputation and could potentially invite lawsuits.
While putting a CSIRP in place; the management has to take into consideration…
Added by Adam Fleming on September 23, 2016 at 6:04am — No Comments
Intro to Forklift Safety
We might be beating a dead horse here, as you've probably already been involved in countless forklift safety training sessions, toolbox talks, etc. It's easy to forget what we've learned in forklift training modules, especially when it's unbelievably dry. But OSHA statistics indicate that there are roughly 85 forklift fatalities and 34,900 serious injuries each year, with 42 percent of the forklift…Continue
Added by Mikaela A. Delia on September 22, 2016 at 10:45am — No Comments
Ah yes, football season. I can already smell the nachos and the buffalo wing sauce wafting through the air from the living rooms of American households. I can already taste the Anheuser-Busch branded beer and I can already hear the light-hearted (and not so light-hearted)
trash talking about opposing teams. Football season is a fun time of year for Americans; where NFL teams are picked in pools and the participation in fantasy leagues are high. We Americans love our football, and we…Continue
Added by Mikaela A. Delia on September 22, 2016 at 10:30am — No Comments
Collections and Appeals for past due amounts can be difficult in any industry; adding the Medical Billing office element to it complicates it further. With this, one has the share of cost for patients, Medicare rules and Regulations, Private Payor contracts, and Collectors without…Continue
Added by Roger Steven on September 22, 2016 at 6:45am — No Comments
Those in the healthcare sector go about their work like they are completing a project. Their work is made up of many parts, all of which they need to approach using many processes and plans. In keeping a tight watch on the budget and the deadline; many aspects of the work get overlooked, as a result of which the outcome suffers.
Each team member has a specific and important task in healthcare. All these have to be done with precision and in close synchrony with the…
Added by Adam Fleming on September 22, 2016 at 5:58am — No Comments
Of late, there has been an explosion in the field of biopharmaceuticals in activities ranging from development to manufacture. Although this augurs well for the industry; there are concerns, nevertheless.
These concerns relate mainly to the inadequacy of the skillsets needed for this industry. There is a widespread feeling in the industry circles that the existing or potential skillsets may not be sufficient for coping with the huge demand the industry is…Continue
Added by Roger Steven on September 22, 2016 at 12:07am — No Comments
Design of Experiments (DoE) is defined as a systematized means with which the factors that go into a process and its intended output can be determined. DoE makes extensive use of statistical and experimentation means. DoE helps to optimize the processes of production in a number of environments in a huge range of industries.
The varied uses of DoE
DoE is useful in a number of applications. For instance, it:
o Helps determine root cause, leading to quick and efficient…Continue
Added by Adam Fleming on September 21, 2016 at 6:27am — No Comments
Whistleblowing is a very important area of the healthcare industry. When exercised properly and with integrity, it helps expose major frauds and saves the industry from many malpractices. There have been instances of whistleblowers bringing many companies into the legal net and helping save frauds.
A whistleblower act, or what is called or qui tam action, can offer huge financial rewards to those who are retaliated against for exposing financial fraud that their company was engaged in,…
Added by Roger Steven on September 20, 2016 at 6:34am — No Comments
Transparency and integrity of the financial interests of clinical investigators is a matter of utmost importance to the healthcare industry in the US. The financial interests of the investigators are directly associated with the results, thinks the FDA. It believes that “financial interests and arrangements of clinical investigators…could affect reliability of data submitted to FDA”.
Keeping this highly important aspect, which could have a serious bearing on the integrity of the…Continue
Added by Adam Fleming on September 20, 2016 at 6:22am — No Comments
Come and join our Family Afternoon CPR / AED workshop. We have had so much interest in helping parents, teachers care takers and day care workers learn the life saving skills of CPR that we decided to provide a chance to sit in our CPR work shop. This training program will prepare each student for any type of CPR emergency that may come up. The goal of this course is to help the students develop the knowledge, skills and confidence to respond in a medical emergency.…Continue
Added by Larry Riley on September 19, 2016 at 8:18am — No Comments
Stark Law, more formally referred to as The Physician Anti-Referral Law (known as Stark II), is a prominent law concerning physician referrals. Healthcare providers that file claims require compliance with the Stark rules. Failure to comply can invite an enforcement action. The fundamental aim of this law is the elimination of malpractices in the healthcare sector. Implemented in stages known as Stark II and Stark III; the Stark Laws consider particular actions on the part of the physician…Continue
Added by Roger Steven on September 19, 2016 at 6:38am — No Comments
The demographic profile of the nation has a direct and very important bearing on the productivity of an organization. There is a common perception that the Baby Boomers are on their way out and are making way for Gen X. While this is true to on the surface, in the sense that Gen X is the next phase of the workforce; the Baby Boomers are certainly not done yet.
The key to getting more out of the American workforce is to analyze how one generation makes way for the next and how the…
Added by Adam Fleming on September 19, 2016 at 5:56am — No Comments