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May 2017 Blog Posts (43)

Nebosh training in Kerala

NEBOSH IGC kerala

Golden wings HSE is n health and care environment exercise institute as long as international credited certificate for NEBOSH, IOSH, OHSAS and fire safety in one year.  A humanity and institution of illustrious scholars or artists, experts that aims to promote maintain values in its particular field.  An organization intended to protect, develop an art language etc., or a school that teaches a particular subject or…

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Added by mani on May 31, 2017 at 10:13pm — No Comments

Stark Law considerations for structuring and auditing medical director and administrative agreements

When structuring and auditing medical director and administrative agreements; the provisions of the Stark Law need to be taken into careful and full consideration. This is because the Stark Law is the operative law for this kind of arrangement.

Implementation of best practices for negotiating and drafting administrative arrangements on behalf of health systems, hospitals, medical groups and…

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Added by Roger Steven on May 30, 2017 at 7:31am — No Comments

Implementing the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

The FDA’s Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food, which was passed on April 6, 2016, has now become final. This is the latest in a series of as many as seven rules that have been getting legislated from January 2013 with the intention of creating a modern, risk-based framework that ensures food…

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Added by Adam Fleming on May 30, 2017 at 5:56am — No Comments

Clarifying the misconceptions about DMFs and Quality Agreements

A Drug Master File (DMF) is a file that lists the materials and processes that have gone into a drug. This submission is made by manufacturers of drugs to the FDA, and has to contain everything that goes into the drug, and has to include not only the materials and the processes; but also confidential information pertaining to the facilities in which the drugs are manufactured. All the inputs that have gone into not just the manufacturing, but also the packaging and storing…

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Added by Adam Fleming on May 29, 2017 at 6:13am — No Comments

HIPAA compliance for offshore vendors

In this age of outsourcing and globalization, and with it, the emerging potential phenomenon of the Internet of Things (IoT); it is quite a tempting proposition for HIPAA Business Associates or Covered Entities to think of outsourcing their processes relating to Protected Health Information (PHI).…

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Added by Roger Steven on May 26, 2017 at 8:30am — No Comments

Meeting equipment validation requirements from the FDA and EU

Putting in place a program for calibrating and maintaining test and measurement equipment is a regulatory requirement from both the FDA, under 21 CFR Part 210 and 211, and relevant EU regulations. Both these agencies have regulations that require this program from manufacturers.

The purpose of this equipment validation program is to ensure these…

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Added by Adam Fleming on May 26, 2017 at 6:24am — No Comments

NEBOSH course in Kolkata

Hi friends are you looking for best NEBOSH course institute in Kolkata then Green World Group is the best place for it. We are providing safety  courses such as NEBOSH,IOSH MS,CPD certified course,national diploma course etc

Contact us:

Mrs. Priya Bose

SR. PRODUCT SPECIALIST

Mob: +91 8420399404…

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Added by Nakul Pratap on May 25, 2017 at 8:14am — No Comments

Why IEC 60825 certification cannot be substituted for 21CFR1040

With a few exceptions, it is necessary for manufacturers, system integrators and importers of lasers or laser containing products to implement best practices for compliance with FDA 21 CFR 1040. This is because The Center for Devices and Radiological Health (CDRH) requests documentation using the current version of their Form 3632 Guide for Preparing Product Reports for Lasers or Products Containing Lasers for laser self-certification submittals, which have to comply with…

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Added by Adam Fleming on May 24, 2017 at 6:31am — No Comments

Seminar Calendar of Upcoming Courses - June to July - 2017

 

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the…

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Added by John Robinson on May 24, 2017 at 5:51am — No Comments

Answers to 5 FAQs Related to Establishing a Drug-Free Workplace

It is not uncommon for workplaces to deal with employees using illicit substances. Employee substance abuse is a problem that is beyond the abuser. Drug and alcohol abuse can easily lead to workplace accidents caused by negligence.



Research conducted by the National Council on Alcoholism and Drug Dependence, Inc. highlights that 70 percent of 14.8…

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Added by Nicole J Gomez on May 24, 2017 at 2:30am — No Comments

MentorHealth Webinar Calendar of Upcoming Courses

MentorHealth webinars are designed to offer professionals in the healthcare industry the knowledge they need in all the areas of the healthcare industry that enables them to excel in their professions. MentorHealth’s trainings bring experts from all the core areas of healthcare and impart learning to help professionals understand and implement all the important issues that matter to their professions. To keep updating your knowledge of regulatory compliance in the healthcare industry, all…

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Added by Roger Steven on May 23, 2017 at 9:05am — No Comments

Webinar Calendar of Upcoming Courses - May to Jun 2017

webinar-training-online-education.jpg

Below is the event description content:

Compliance4All webinars are just what professionals in the regulatory

compliance areas need for scaling up in their careers. With a collection of

the most erudite experts on regulatory compliance being available at a click

in the comfort of your preferred location; regulatory compliance could not

get any simpler and effective!

Compliance4All’s experts help you unravel all the knowledge you need…

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Added by Adam Fleming on May 22, 2017 at 7:53am — No Comments

Understanding CARC and RARC

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…

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Added by Roger Steven on May 19, 2017 at 8:44am — No Comments

Meeting labeling requirements of various drug products

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…

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Added by Adam Fleming on May 19, 2017 at 6:17am — No Comments

“Understanding the practical application of statistics?”

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

o  Performing…

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Added by John Robinson on May 19, 2017 at 5:51am — No Comments

The Stark Law and key considerations for physician employment agreements

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

 

-       …

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Added by Roger Steven on May 17, 2017 at 7:00am — No Comments

Regulations governing how combination products are regulated

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…

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Added by Adam Fleming on May 17, 2017 at 6:40am — No Comments

Knowledge of employment laws is absolutely crucial for organizations

As the new presidential administration settles in in the US, employment law…

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Added by John Robinson on May 17, 2017 at 5:56am — No Comments

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Kyle C. Johnson posted a discussion

[General Industry] What is your workplace's policy on headphones? Working on one currently.

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their phones at any time, anywhere. Even the PIT drivers. It's insane. My initial reaction is to say NO HEADPHONES WHATSOEVER, but my ops manager is concerned it will drastically reduce morale. I suggested that each department should have their own radio and they can play music for everyone to hear, at a…See More
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John Robinson posted a blog post

Nutrition Facts labels of pure maple syrup and honey

FDA Commissioner, Scott Gottlieb, has announced a major overhaul of the FDA’s update to the Nutrition Facts label on products. This overhaul, the first in nearly twenty years, is aimed at empowering consumers by furnishing information on Nutrition Facts labels pure maple syrup and honey that ensures greater accuracy and is more science-based. With this, the FDA wants to help consumers make more informed and healthier choices.This update to the Nutrition Facts label has incorporated the latest…See More
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[General Industry] What is your workplace's policy on headphones? Working on one currently.

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their…Continue

Tags: general, industry, distraction, music, phone

Started by Kyle C. Johnson yesterday.

AI Machine Learning In Businesses How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?

How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?However you define уоur оwn ѕmаll business, it tоо can tаkе advantage оf thе AI/ …Continue

Tags: elite, crest, technologies, intelligence, Artificial

Started by emmablisa on Monday.

Distracted Driving 1 Reply

****WARNING**** Despite the fact that this is a life event portrayed by actors, it's graphic. This video should be part of…Continue

Tags: texting, fatality, safety, car, driving

Started by Wendy. Last reply by Jen McDade Dec 5.

Safety update: OSHA announces fit-test procedures 1 Reply

Fabricators as well as other workers may be required to use respirators to protect themselves from inhaling fumes, particles, or dust when performing cutting, grinding, welding, coating, or painting,…Continue

Tags: online, training, Safety, workplace, PPE

Started by Safety Training International. Last reply by Jen McDade Dec 4.

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