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Safe and effective as a non PMA-subjected legally marketed device

A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).

A medical device company has to submit a product for PMA when it manufactures or makes changes and modifications that could substantially affect safety and effectiveness requirements under 21 CFR 807 and…

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Added by Adam Fleaming on April 5, 2018 at 6:59am — No Comments

Introduction to Machine Learning With Python

Some useful information to help you Machine Learning with Python

Machine Learning is a very common technique that is considered by a very large number of businesses across the globe. Due to its increasing scope and pros, people all over the world are learning Machine Language with Python. If you are one among them, we guide you to learn the same in a very simple manner. You will find information on different…

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Added by Elena Lauren on April 4, 2018 at 7:22am — No Comments

5 Safety Signs to Have in the Workplace

One of the most effective ways to communicate safety in the workplace is through visuals. By implementing clear and easy-to-see safety signs, everyone will be able to identify hazards, instructions or regulations easily. Regardless of the industry you are in, these 5 signs should be in your workplace.

1. Danger signs - Every organization should map out high hazard areas, along…

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Added by Jesse Allred on April 2, 2018 at 2:39pm — No Comments

PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001

PharmAbcine Inc., a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TTAC-0001 for “treatment of Glioblastoma Multiforme.”

“We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001 for GBM treatment since we have been preparing for clinical studies of TTAC-0001 plus KEYTRUDA®…

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Added by Adam Fleaming on April 2, 2018 at 7:29am — No Comments

Understanding ANSI z87.1

The American National Standards Institute (ANSI) is a nonprofit, non-governmental organization that works to improve the efficiency of organizations, often by improving safety.

 

The set of standards known as ANSI Z87.1 is specifically focused on Occupational and Educational Personal Eye and Face Protection Devices. These…

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Added by Jesse Allred on March 27, 2018 at 12:16pm — No Comments

How to understand the Pharmaceutical Regulatory Affairs

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

Pharmaceutical1-banner https://compliance4all14.files.wordpress.com/2018/03/pharmaceutical1-banner.jpg?w=706&h=664 706w,…

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Added by Adam Fleaming on March 26, 2018 at 6:53am — No Comments

How to understand the Pharmaceutical Regulatory Affairs

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

Pharmaceutical1-banner https://compliance4all14.files.wordpress.com/2018/03/pharmaceutical1-banner.jpg?w=706&h=664 706w,…

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Added by Adam Fleaming on March 26, 2018 at 6:53am — No Comments

Appropriate Safety Masks to Use to Avoid Inhaling Asbestos

Workers from practically all trades, from factory workers to roofers, carpenters, auto mechanics, plumbers, and others are in danger of being exposed to asbestos on the job. Studies…

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Added by Jam Blanco on March 22, 2018 at 1:36pm — 1 Comment

Virtual healthcare has to be understood and used for what it can offer

Among the many offshoots of the growth of technology; virtual healthcare is a very recent and important development. In simple language, virtual healthcare, a term easy enough to understand, is the use of technologies that enable remote consultation and monitoring of healthcare.

Putting technologies to remote use has been in use for a while now, what with corporate entities carrying out conferences and virtual conferences at the push of a button. Virtual…

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Added by Adam Fleaming on March 22, 2018 at 7:34am — No Comments

The most comprehensive and low-cost package

It is significantly been noted that in case of complicated medical treatment and care lot of cost is incurred and at the same time one has to keep in mind the quality of treatment. In case you consider the treatment cost in the European countries or in America it’s just amazingly huge which become difficult for the average citizen there to afford. Presently India is the ultimate destination where cost and quality of treatment are concerned, to address severe health complications. A…

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Added by Silvia Watson on March 21, 2018 at 5:53am — No Comments

Top Cal/OSHA Violations and How to Avoid Them

California’s Division of Occupational Safety and Health or Cal/OSHA is responsible for enforcing workplace safety standards in the state. According to the laws of the state, all employers have to have an effective and running IIPP or Injury and Illness Prevention Program in place that can prevent health and safety issues in the workplace. This includes but is not limited to plans for workplace hazards, safety communication, and safety training programs.…

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Added by Jam Blanco on March 20, 2018 at 11:05am — No Comments

Good Documentation Practices Relating to USP

Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for. GDP is also essential to keep track of and maintain control at all stages of the process and the product. GDP is thus a core requirement of a thoroughly developed Quality System.…

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Added by Adam Fleaming on March 20, 2018 at 7:09am — No Comments

NEBOSH course in Hyderabad - Batch Photos

NEBOSH course in Hyderabad

Added by Nakul Pratap on March 19, 2018 at 5:43am — No Comments

NEBOSH training course in Chennai

NEBOSH course in Chennai

It truly is this NEBOSH Course throughout Chennai,Tamilnadu which provides this person using broad information relevant for you to occupational health and safety problems. NEBOSH qualification seems for you to authorize the person to become knowledgeable and also know how risks with various types could be managed resourcefully and also properly. Its considered becoming a moving stone, specially for all those preparing to have a new vocation…

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Added by Nakul Pratap on March 17, 2018 at 5:31am — No Comments

NEBOSH training in Chennai - Batch Photo

NEBOSH training in Chennai

One of the considered health and safety certification in the United Kingdom. is NEBOSH general certificate. NEBOSH qualification training has been done by more than 10000 folks right from it is beginning from the calendar year 1989 in addition to much more are getting started with on a daily basis. The reputation of NEBOSH accreditation teaching is no more…

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Added by Nakul Pratap on March 17, 2018 at 3:04am — No Comments

Eco-Friendly Parking Tips

This was created by Westfalia Parking Solutions

Added by Westfalia Parking on March 16, 2018 at 5:00pm — No Comments

NEBOSH training institute in Kolkata

NEBOSH course in Kolkata

NEBOSH testimonials …

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Added by Nakul Pratap on March 16, 2018 at 8:00am — No Comments

NEBOSH course in Hyderabad

NEBOSH course in Hyderabad

NEBOSH testimonials…

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Added by Nakul Pratap on March 16, 2018 at 6:30am — No Comments

NEBOSH training institute in Chennai

NEBOSH institute in Chennai

HSE interview questions …

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Added by Nakul Pratap on March 16, 2018 at 5:49am — No Comments

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Successfully Negotiating The Labor Agreement at Training Doyens 26468 E Walker Dr

July 17, 2018 from 1pm to 2:30pm
OVERVIEWThis Webinar is intended to outline the concepts of successful negotiationhighlighted by learning the preparation, The Tactics, The methods of getting Agreement, Effective Clausing and how to cost out your Agreement. We will address the needs of the Employer and the Union building the Relationship upon which this Agreement will stand for years to come.WHY SHOULD YOU ATTENDWe will discuss Preparing to Negotiate,…See More
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Why Nebosh and Benefits of Nebosh Course in Chennai ? How to Join

Organisations use NEBOSH courses to assure that their workers are well knowledgeable of all expected safety standards within the work environment. Businesses that assure all Worker go through at least an entry level NEBOSH safety course experience lesser accident rates in the work environment. Those who advance their workers to better courses with sector specific training guidelines experience even lower accident rates within the work environment.Learn Our…See More
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5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Power BI Visualization Types

Visualizations in Power BI displays the visual insights from a data. In power bi service a visual can be pinned from reports to create dashboards. Visuals are used in reports.List of visualizations…Continue

Tags: COURSE, TRAINING, BI, POWER

Started by Azharuddin May 15.

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