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Expect drastic changes to the in-vitro diagnostics market in the upcoming years

The in-vitro diagnostics (IVD) market is a diverse and fast changing one. Of late, one of the significant changes that happened to it resulted from the passage of the Final Rule. As part of the Affordable Care Act (ACA) or Obamacare, the Centers for Medicare and Medicaid Services (CMS) introduced the Final Rule to the 2014 Protecting Access to Medicare Act (PAMA) in mid-2016, which is set to make a significant impact on the in-vitro diagnostics market by delaying implementation of…

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Added by Adam Fleaming on February 6, 2017 at 6:19am — No Comments

Quality is everything for a product or service

Quality is everything for a product or service. Quality is defined in different ways. One of the well-known definitions of Quality is the ability of a product or service to reach expected levels of excellence. This is a simple theoretical definition. In practice, though, Quality is a highly painstaking area of activity that is necessary across all functions of all industries. If a product does not meet its quality requirements or criteria, it is doomed to failure.…

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Added by John Robinson on February 3, 2017 at 8:01am — No Comments

Supplier Management Conference for Medical Device Manufacturing in HONG KONG

Overview:

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery…

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Added by John Robinson on February 1, 2017 at 4:30am — No Comments

Water System Validation in Pharmaceuticals Industry 2017

Overview:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement…

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Added by John Robinson on January 31, 2017 at 5:09am — No Comments

Research and practice need to go hand in hand

Research and practice are two sides of a coin. Most actions result from thoroughly and well carried out research, but somehow, research has largely been confined to being just an academic activity that is carried out for satisfying the professional urges of the researchers. Translating research into practice, however, is very important, because research in itself does not mean much in the real world if what is obtained from it is not implemented. Likewise, many practical, real world products…

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Added by kate smith on January 27, 2017 at 3:46am — No Comments

Effective meetings are a means to improved performance

Effective meetings become a very critical means to improving the organization’s performance. Meetings are absolutely indispensable as a vehicle for sharing thoughts and conveying important decisions. Is there any organization that does not conduct meetings? Meetings are the most…

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Added by kate smith on January 25, 2017 at 5:10am — No Comments

Statistics for the Non-Statistician: Is it necessary?

Statistics for the non-statistician: Isn't this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first…

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Added by John Robinson on January 25, 2017 at 4:58am — No Comments

Recommended Practices for Anti-Retaliation Programs

WASHINGTON - The Occupational Safety and Health Administration today issued Recommended Practices for Anti-Retaliation Programs to help employers create workplaces in which workers feel comfortable voicing their concerns without fear of retaliation. The recommendations are intended to apply to all…

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Added by Henry Wilter on January 24, 2017 at 6:34pm — No Comments

Top trends in management accounting

Top trends in management accounting need to be taken into account by professionals in this area of work. As a field, management accounting has evolved and come a long way in the last few decades. For this reason, professionals in this field need to be aware of the top trends in management accounting if they have to stay ahead of the curve. Disciplines or activities that constitute top trends in management accounting yesterday have become part of standard practice today. Likewise, what people…

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Added by kate smith on January 24, 2017 at 4:10am — No Comments

Management for Medical Device Industry

A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global…

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Added by John Robinson on January 23, 2017 at 7:46am — No Comments

Documenting Employee Discussions –a very important function for HR

Documenting employee discussions is a very tricky and at times painful activity for organizations. While it is crucial for HR for a number of reasons, it is a difficult habit for the other employees to imbibe. Documenting employee discussions is important from a legal perspective,…

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Added by kate smith on January 23, 2017 at 6:08am — No Comments

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the…

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Added by John Robinson on January 20, 2017 at 5:50am — No Comments

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects for a number of valid reasons. One of the main reasons is that medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug “active pharmaceutical ingredients” to achieve the clinical therapeutic effect.…

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Added by Adam Fleaming on January 20, 2017 at 5:19am — No Comments

Conflict management is not about chopping heads

Conflict management is not about chopping heads. Chopping heads is not a wise option or decision when it comes to conflict management. Many a time, a session in which the parties in a conflict can be made to come together and sit and talk can resolve conflict. Conflict management should not…

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Added by kate smith on January 20, 2017 at 2:11am — No Comments

Sweating Slab Syndrome Safety Hazards

Sweating Slab Syndrome presents many dangers in industrial facilities and other buildings that have concrete floors. 

Sweating Slab Syndrome is characterized by the regular formation of condensation on a concrete floor. Not only can this lead to slips and falls, but can also lead to mold growth and many other dangers.

Go Fan Yourself has created an infographic that highlights the dangers of Sweating Slab Syndrome and provides some tips for alleviating Sweating Slab…

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Added by Nikki Heinkel on January 19, 2017 at 12:18pm — No Comments

Working at height is one of the UK's leading causes of workplace fatalities & injuries. These pointers will reduce risks & make working at height safer.

Working at height is the leading cause of workplace fatalities & injuries in the UK. In 2013/14, the Health and Safety Executive published statistics which showed that working at height was responsible for more workplace fatalities than any other…

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Added by Alex on January 19, 2017 at 12:04pm — No Comments

A lot of diligence has to go into writing investigative reports

 

When writing investigative reports in an organization, the person in charge has to show utmost diligence. A properly researched, well-articulated investigative report has the power of ridding the organization of a bad employee. On the other hand, if due diligence has not gone into…

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Added by kate smith on January 19, 2017 at 5:56am — No Comments

Alternatives to AQL sampling plans do exist

Alternatives to AQL sampling plans do exist, but companies need to be aware of them and explore them. Acceptance Quality Limit, or AQL, is applied as a benchmark in most manufacturing organizations to inspect the quality of products they purchase. It is only when the product meets AQL that the receipt is acknowledged and the payment made.

So, what is AQL?

What is AQL? In simple terms, AQL, which expands to Acceptance Quality Limit, is what…

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Added by Adam Fleaming on January 19, 2017 at 5:06am — No Comments

Simulations are a powerful hiring technique

Simulations are a powerful hiring technique for a number of important reasons. Selection of personnel –the right one of course –is a very difficult task for even the most experienced HR professional. When a candidate answers all questions relating to the job…

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Added by kate smith on January 18, 2017 at 5:05am — No Comments

FDA Regulation of Combination Products is important to understand

FDA regulation of combination products is a very important aspect to keep in mind for pharmaceutical manufacturers. This is because of the complex nature of combination products. The definition for combination products is set out in 21 CFR 3.2 (e). Combination products assume importance in the industry because they combine two more drugs from different categories. This is what makes them unique. If a product is made out of two or more drugs from the same category, it does…

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Added by Adam Fleaming on January 18, 2017 at 5:02am — No Comments

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Adam Fleaming posted a blog post

Establishing Latest Quality Systems in medical device and pharmaceutical industries

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as…See More
16 hours ago
Adam Fleaming posted a blog post

Right now Medical device hazard analysis, the core of medical devices

Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.So, what is medical device hazard analysis? Medical device hazard analysis may be defined…See More
yesterday
Scott V posted a discussion

OSHA and Machine Guard Door Safety???

We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements.  We are building a small machine system that includes some pneumatic components and some heated plates inside a small guard system.  We include emergency stops on the machine and if they are actuated it removes all electric current and dumps all air pressure from the machine.  We have several electrically interlocked doors that can be opened to…See More
Friday
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OSHA and Machine Guard Door Safety???

We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements.  We are building a small machine system that…Continue

Tags: electric, osha, air, door, interlocked

Started by Scott V on Friday.

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.

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