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January 2017 Blog Posts (22)

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

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

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

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 Fleming on January 20, 2017 at 5:19am — 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

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 Fleming on January 19, 2017 at 5:06am — 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 Fleming on January 18, 2017 at 5:02am — No Comments

Post market surveillance needs to be robust to avoid penal regulatory action

Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.

Post market surveillance is, in simple terms, the monitoring of the performance and…

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Added by Adam Fleming on January 17, 2017 at 6:56am — No Comments

Compliance for medical devices is a very expansive area for manufacturers of medical devices

Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices…

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Added by John Robinson on January 16, 2017 at 5:46am — No Comments

How to implement 21 CFR Part 11, which is about Compliance for Electronic Records and Signatures?

How to implement 21 CFR Part 11, the regulatory guideline which deals with compliance for electronic records and signatures, is a challenge for professionals in the medical devices and pharmaceutical industries. The FDA has set out 21 CFR Part 11 to help the regulated industries that come under its purview to structure their business processes…

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Added by John Robinson on January 13, 2017 at 5:17am — No Comments

ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global…

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Added by John Robinson on January 13, 2017 at 4:30am — No Comments

Regulatory Filing Requirements for medical devices in Japan

Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing…

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Added by John Robinson on January 12, 2017 at 4:51am — No Comments

Work tools: key stats and areas of concern

Although we all know intuitively that power tools can be exceptionally dangerous if used without due care and attention, it remains far too easy to fall into the trap of thinking that the ones we’re most accustomed to are somehow made safer by dint of our familiarity with them.

 

However,…

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Added by Alex on January 11, 2017 at 11:04am — No Comments

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical…

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Added by John Robinson on January 11, 2017 at 5:01am — No Comments

HIPAA Security Rule

Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult.

HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health…

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Added by John Robinson on January 10, 2017 at 4:41am — No Comments

Emerging Issues in Food Safety-Globally

The Global Food Safety Initiative is a private enterprise by those in the food industry aimed at offering guidance to the food industry for making food chain safer. This industry-driven initiative seeks to provide thought leadership on the various aspects of food and guides the food industry on implementing safety standards along all the points in the food…

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Added by John Robinson on January 9, 2017 at 6:42am — No Comments

GMP Compliance for Pharmaceutical Laboratories

In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory's activities.

Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various…

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Added by John Robinson on January 9, 2017 at 6:00am — No Comments

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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 yesterday.

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.

Proper guarding protects workers: Six steps to focusing on your employees' needs 1 Reply

When people think of machine guarding, usually they think of devices to protect people from the moving parts on machinery.When people think of machine guarding, usually they think of devices to…Continue

Tags: training, compliance, PPE, Training, Safety

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

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