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September 2016 Blog Posts (32)

Part 11 inspections from the FDA and ways of steering clear of inviting 483’s and Warning Letters

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…

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Added by Adam Fleming on September 30, 2016 at 6:56am — No Comments

Security Alert: Best Tech Tips for College Students to Protect Their Identity

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…

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Added by Michael Zhou on September 29, 2016 at 8:56am — No Comments

Tightening carrier food safety issues can save costs for the food and logistics industries

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…

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Added by Adam Fleming on September 29, 2016 at 5:59am — No Comments

Getting laboratory noncompliance practices out of the way

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…

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Added by Adam Fleming on September 28, 2016 at 6:15am — No Comments

Choosing a health and safety training provider

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 money by knowing exactly what you want before embarking on any training…

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Added by Alex on September 27, 2016 at 8:35am — No Comments

Care should be taken while signing the Electronic Health Record license agreement

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:

  • Whether and how often the vendor may make online portions of the software unavailable for maintenance or other issues
  • How many people may use the software and on how many machines…
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Added by Roger Steven on September 27, 2016 at 7:22am — No Comments

Conducting clinical trials effectively requires project management skills

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 of the treatment, as well as to ensure the wellbeing and safety of the patient.

Given the complexity…

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Added by Roger Steven on September 26, 2016 at 7:47am — No Comments

Handling an IRS audit

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…

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Added by Adam Fleming on September 26, 2016 at 7:28am — No Comments

Elements of a Cyber Security Incident Response Program

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…

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Added by Adam Fleming on September 23, 2016 at 6:04am — No Comments

20 Important Tips for Forklifts

Intro to Forklift Safety 

Types of Forklifts Fatalities no bkgd 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…

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Added by Mikaela A. Delia on September 22, 2016 at 10:45am — No Comments

Football Season: Safety Always Wins

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…

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Added by Mikaela A. Delia on September 22, 2016 at 10:30am — No Comments

Making Collections and Appeals easier

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 experience in medical terminology needed for successful claims appeals to deal…

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Added by Roger Steven on September 22, 2016 at 6:45am — No Comments

Managing healthcare projects with ease and simplicity

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…

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Added by Adam Fleming on September 22, 2016 at 5:58am — No Comments

Transitioning to a career in biopharmaceuticals requires skillset upgradation

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…

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Added by Roger Steven on September 22, 2016 at 12:07am — No Comments

DoE helps in optimizing processes and output in a number of ways

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…

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Added by Adam Fleming on September 21, 2016 at 6:27am — No Comments

Understand the False Claims Act to be a better whistleblower

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,…

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Added by Roger Steven on September 20, 2016 at 6:34am — No Comments

Exploring the FDA’s guidance on financial disclosure by clinical investigators

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…

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Added by Adam Fleming on September 20, 2016 at 6:22am — No Comments

Family Afternoon CPR Work Shop

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.…

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Added by Larry Riley on September 19, 2016 at 8:18am — No Comments

Physician Leases need to be structured under the new 2016 Stark Rules

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…

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Added by Roger Steven on September 19, 2016 at 6:38am — No Comments

Designing your retail store for the old and new generations

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…

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Added by Adam Fleming on September 19, 2016 at 5:56am — No Comments

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If you are taking into consideration for any plastic surgery treatment, discovering the best plastic surgeon is of prime importance. There might be several plastic surgeons supplying plastic surgery, as well as you have to find a plastic surgeon that can aid accomplish your visual objectives. As laser lipo is an advanced procedure, just a doctor having the right skills can guarantee you risk-free and optimal outcomes. Pointed out here are some of the factors for choosing the…See More
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A guide to keeping your kids safe at home

As a parent - no matter how old your child is - you have a number of responsibilities to your child: to make sure they are properly taught important life skills; to make sure they’re happy and healthy; and, most importantly, to ensure that their home is a safe place for them. There are many elements to this, and there are many dangers facing people in everyday life, but every parent must keep their child safe at home, whilst striking a balance between keeping them safe and healthy and…See More
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Workplace safety for workers other than your own 3 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Paul Lancaster May 28.

Imagine a technology which is an artificial muscle and is integrated into textiles...

Such a smart textile has huge application potential and can support people in many different ways. The garment would use haptic feedback (i.e. the use of touch to guide the user) or could serve as a…Continue

Started by Ulla Siegel May 28.

Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

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