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September 2016 Blog Posts (36)

Social Media at work: Quandary for organizations

Allowing use of social media at work is a major decision for many organizations, considering that its pros and cons weigh almost equally.
The social media being the double edged sword that it is; allowing its use at work is a "shall we, shall we not" sort of conundrum for most organizations. While on the one hand, their use can be a…
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Added by kate smith on September 30, 2016 at 7:36am — No Comments

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 Fleaming 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

HR Documentation is a Vital Aspect of Organizations

HR documentation is of vital importance to organizations. Unless its nuances are mastered; organizations can fall into embarrassing and damaging pitfalls.

HR documentation is one of the most important aspects at the workplace. The habit of HR documentation is usually imbibed into HR professionals from early on in their careers. But what does HR document?
HR documentation resonates with the spirit of…
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Added by kate smith on September 29, 2016 at 7:18am — 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 Fleaming 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 Fleaming on September 28, 2016 at 6:15am — No Comments

Components of a Compensation & Performance Management Program

Compensation and performance management has emerged as a specialized area of management and HR. A compensation and performance management program is essential for any organization that seeks to get the best out of its employees.

At a very basic level, performance management can be described as the assessment of an employee's performance at work. This is done during a fixed period of time and is meant to help management evaluate the efficiency the said employee brings into work. How this is… Continue

Added by kate smith on September 28, 2016 at 5:22am — 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…

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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

Putting a Performance Appraisal Toolbox in Place Helps

performance appraisal toolbox is an objective checklist of the ingredients that go into an appraisal. Managers have to learn what to put into this toolbox.

An appraisal is a headache for any…

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Added by kate smith on September 27, 2016 at 5:00am — 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…

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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 Fleaming 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 Fleaming 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…

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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 Fleaming 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 Fleaming 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

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Adam Fleaming posted a blog post

Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?This is simply not the case. Quality and compliance are built into a medical device…See More
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Adam Fleaming posted a blog post

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that carrying changes out is neither…See More
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OSHA 500 and 510 9 Replies

Hey Guys,How many of you have taken the 510 and 500 OSHA Trainer course? I am thinking about taking these 2 classes and become an OSHA trainer for my company. What are your guys thoughts on the…Continue

Started by Alfred Good. Last reply by Mymic Mar 15.

OSHA Training, Standards & Best Practices 3 Replies

Get trained on OSHA regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best…Continue

Tags: Webinar, Training, 2011, OSHA, compliance

Started by admin. Last reply by Mymic Mar 15.

FORKLIFT TRAINING CLASSES 21 Replies

Any ideas on how to make Forklift Training Classes more interesting and fun?

Started by Marcia Whatley. Last reply by Mymic Mar 15.

Our Safety in Their Hands 16 Replies

This thought provoking workplace safety infographic features the top 5 organizations that have made the biggest impact on occupational health and safety. It features the U.S governments OSHA,…Continue

Started by Lorenzo Miguel. Last reply by Mymic Mar 15.

OSHA Training on the GHS Labeling System 3 Replies

Anyone wanting to get educated about the new OSHA training requirements on GHS labeling systems should view the free online tutorial at…Continue

Tags: hazcom, 1910.1200, labeling., training, osha

Started by Curtis Chambers, CSP. Last reply by Mymic Mar 15.

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