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November 2016 Blog Posts (27)

Editing skill for scientific writers

For many professionals, writing skills are learned while they are on the job. In many cases, they would go by a preferred style or other documents or style guides that help to put a certain style in place. Editing, however, is rarely taught. Worse, the perception most people have of editing is that it is revising or rewriting a work. But the truth is different. Editing gives shape to a document. It helps to perfect and sculpt it. The big question most editors face…

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Added by Roger Steven on November 29, 2016 at 6:10am — No Comments

Making financial institution’s payment franchise stronger

Financial institutions have long been the most important source of payments for their customers. Of late, though, with an increase in competition and the advent of new non-bank entries into the marketplace, financial institutions have come under a lot more strain than they used to be.

Financial institutions need to reinvent themselves in a number of ways. They need to adapt novel strategies to…

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Added by Adam Fleming on November 25, 2016 at 5:03am — No Comments

Regulating Nanotechnology in food

Nanotechnology, a part of Quantum Physics (QP), is growing fast and has myriad uses. Nanotechnology is all about size and self-assembly. While QP deals with subatomic particles and waves; Nano relates to the atomic and molecular level. Atomic behavior and properties get dramatically changed at the Nano level. Of note are properties such as color change due to refraction of light. Gold, packaging and chemistry are some of the well-known areas into which…

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Added by Roger Steven on November 25, 2016 at 4:50am — No Comments

The importance of “Management Responsibility” for medical device companies

Compared to bigger actions, Recalls, 483s, Warning Letters and consent decrees are only some of the milder parts of punishments that the FDA could impose on a medical device company that fails to meet regulatory requirements. The bigger actions can include seizure, injunction, and civil money penalties. The Park Doctrine allows executives to even be sentenced to prison.

In the…

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Added by Adam Fleming on November 22, 2016 at 4:50am — No Comments

Construction site essentials: anemometers

Keeping an eye on weather conditions is, of course, a pretty crucial task on most work sites. Potential injuries from worker slips or falls, along with the risk of damage caused by improperly secured loads or machinery, are among the most pressing health and safety concerns on busy sites – and inclement weather conditions, particularly strong or changeable winds, will…

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Added by Alex on November 18, 2016 at 9:07am — No Comments

Controlling pests in food processing and foodservice

Food establishments continue to be a major source for pests due to the changes brought about in the means and ways by which food is produced and handled and in the ways of preparation techniques and eating habits. The pests in turn are sources for illness-causing microorganisms. The more knowledge about pest control at their disposal; the better it is for food processing and foodservice personnel, because this is essential for ensuring a safe food supply for consumers.…

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Added by Adam Fleming on November 17, 2016 at 4:43am — No Comments

Lineament analysis as a modern tool to look for ore deposits

For those in the field of exploration, there is a need to zero in on an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. This methodology should help explorers concentrate their exploration efforts over new areas keeping their budget in control, armed even with limited or nonexistent geological information.…

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Added by Adam Fleming on November 16, 2016 at 4:47am — No Comments

Carrying out a HIPAA and HITECH risk analysis



The importance of conducting a risk analysis updating it can be gauged from the fact that failure to conduct a written risk analysis qualifies as “willful neglect”, which carries the highest Civil Money Penalty (“CMP”). This cannot be waived by the DHHS unlike violations that happen due to a reasonable cause.

Since risk analysis is a required implementation specification under the Security Rule, failure to do one amounts to willful neglect. If the civil…

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Added by Roger Steven on November 15, 2016 at 5:23am — No Comments

Getting a grasp of the FDA’s New Enforcement of 21 CFR Part 11

That the FDA has become more rigorous in the enforcement of Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program is evident in this: In just the last three years, it issued more than 30 Warning Letters with Part 11 and data integrity violations. The most common citations are related to not only inadequate integrity, security and availability of electronic records, but also to validation of software and computer systems.…

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Added by Adam Fleming on November 15, 2016 at 4:44am — No Comments

Putting in place food processes that facilitate traceability and recall

The Food Safety Modernization Act (FSMA) has strengthened the FDA’s enforcement authority. The FDA now has the authority to not only mandate product recalls; the records and information they may request to see have increased as well. What has also gone up is the FDA’s documentation review authority.

Allergen mislabeling microbiological and foreign material contamination are the…

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Added by Adam Fleming on November 14, 2016 at 4:38am — No Comments

ISQEM Board Directors nominations for 2017 -2020

This is your chance to raise you own professional profile in the HSQE industry by becoming a Board Director of ISQEM, and help increase our membership worldwide. …

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Added by Wayne Harris on November 12, 2016 at 6:00am — No Comments

Understanding the New Laws and Qualifications of the Specialty Board Certification

A common qualifying measure of physician ability is the medical specialty board certification. Because the requirements of the board are increasing; the laws that restrict such use are on the rise.

A webinar from MentorHealth, a leading provider of professional trainings for the healthcare industry, will offer learning on the new laws and qualifications of…

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Added by Roger Steven on November 11, 2016 at 6:13am — No Comments

Managing a medical device recall efficiently and effectively

A medical device recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls are made when a) a medical device is defective; b) when it could be a risk to health, or c) when it is both defective and a risk to health.…

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Added by Adam Fleming on November 11, 2016 at 4:39am — No Comments

Understanding the myths and realities of HIPAA and BYOD

What can be and cannot be done with the use of personal devices under HIPAA is something practices and businesses that need to be compliant with the provisions of HIPAA need to be thoroughly aware of.

With changes expected in 2016 relating to personal devices as well as emailing and texting; staying compliant is extremely important to protect one’s practice or…

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Added by Roger Steven on November 10, 2016 at 5:05am — No Comments

Making Big Data big in terms of effectiveness

Our world today is unthinkable without data. We seem to be flooded by it. Day in and day out, the world processes trillions of bytes. Big Data seems to be everywhere and has compounded our already heavy reliance on data.

But has this proliferation of data made any significant difference to our lives? Has it made our business decision-making any more effective or insightful?…

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Added by Adam Fleming on November 10, 2016 at 4:23am — No Comments

Key Legal Considerations when Structuring Physician Employment Agreements



Compliance with the Stark Law has become more than just a compliance issue. It is an Enterprise Risk Management issue, as the substantial awards and settlements in recent enforcement actions indicate. Managing their compliance and enterprise risk by ensuring that their physician employment arrangements are defensible under the Stark Law is now an…

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Added by Roger Steven on November 9, 2016 at 7:27am — No Comments

The criticality of determining the right sample size

Among the most important aspects that need to be taken into consideration in any application is the sample size. The sample size, when taken accurately, can be a very reliable guide to the whole. When the wrong sample size is taken for magnification, it could lead to wrong results, throwing the whole exercise into disarray. Determining the right sample size is thus of utmost importance to any application. There are scientific and verifiable means of doing this.…

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Added by Adam Fleming on November 9, 2016 at 4:24am — No Comments

Ensuring sanitization of food products

Maintaining clean conditions in the entire food operation is essential for ensuring effective sanitation in the food industry. This can be brought about only when the residual microorganisms are destroyed after the production, storage and service areas of food establishments are cleaned thoroughly.

washing-tomato-2500 Ensuring a microorganism-free environment is a huge challenge for those in the food industry. This is because activities related to food, such as food production, handling,…

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Added by Adam Fleming on November 8, 2016 at 5:01am — No Comments

An understanding of the EC 1223/2009

The European Co smetics Products Regulation (EC) 1223/2009 (CPR), which became fully operational from July 2013, is a game changer in many ways, as it is considered a most contemporary regulatory framework concerning state-of-the-art of cosmetic science and product technology.

It sets out vastly harsher conditions for compliance of cosmetic products that are manufactured…

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Added by Roger Steven on November 8, 2016 at 4:57am — No Comments

Current trends in Maintaining an Effective CAPA Program and Using Risk Assessment Tools

A measure of the criticality of CAPA to medical device manufacture can be ascertained from the fact that the FDA considers the strength of a manufacturer’s CAPA program as the criterion for deciding how strong or weak he is. Given this fact, it pays to have a watertight CAPA system in place.

Risk-based CAPA is the latest stage in the evolution of the CAPA model. These days, the medical devices industry is using various risk-based approaches and tools to set-up,…

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Added by Adam Fleming on November 7, 2016 at 4:52am — No Comments

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INFRARED SPECTROSCOPY Is Crucial to Your Business. Learn Why!

Near-Infrared Spectroscopy, NIR or NIRS, is considered a superior method assay to traditional ones, which are destructive and also reduce the number of doses for sale. It overcomes these drawbacks by being both rapid and nondestructive, which helps it respond to the pressures in the pharma industry for generating more and more data, which leads to more assays that bring these inevitable downsides.In being responsive to the physical and chemical environment of…See More
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Workplace safety for workers other than your own 1 Reply

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 Jen McDade on Thursday.

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 on Tuesday.

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.

Important of Warning sign 1 Reply

Warning sign is a type of traffic sign that guide a hazard ahead on the road. Having proper warning sign on the road provide a healthy environment.Continue

Tags: Signs, Workplace, Safety, Sign, Warning

Started by healthandsafetysigns. Last reply by Jen McDade Jan 14.

Workers paticipation in safety management 2 Replies

Workers paticipation in safety management is the aspect which is required to be implemented in the OHSAS 18001 2007 version. , I invite our experience community members to share their views on the…Continue

Tags: management, safety, in, paticipation, Workers

Started by SafetyRaja. Last reply by Tara safe Dec 27, 2018.

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