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 because engineers and other non-biologists also need this training if they are involved with any aspect of…Continue
Added by John Robinson on January 31, 2017 at 5:09am — No Comments
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 glance, statistics for the non-statistician may appear unnecessary and redundant,…Continue
Added by John Robinson on January 25, 2017 at 4:58am — No Comments
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…Continue
Added by Henry Wilter on January 24, 2017 at 6:34pm — No Comments
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 market, and is expected to grow by over 20 percent by 2016.
While many global…
Added by John Robinson on January 23, 2017 at 7:46am — No Comments
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 path it chooses to take by putting in place a set of documents that is prescriptive and hierarchical,…Continue
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 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.…Continue
Added by Adam Fleming on January 20, 2017 at 5:19am — No Comments
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…Continue
Added by Nikki Heinkel on January 19, 2017 at 12:18pm — No Comments
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 professional activity. It also revealed that working at height was the…Continue
Added by Alex on January 19, 2017 at 12:04pm — No Comments
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…
Added by Adam Fleming on January 19, 2017 at 5:06am — No Comments
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…
Added by Adam Fleming on January 18, 2017 at 5:02am — No Comments
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…
Added by Adam Fleming on January 17, 2017 at 6:56am — No Comments
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 to comply with. The FDA requires strict compliance with its laws and requirements because it is charged with the task of ensuring the…Continue
Added by John Robinson on January 16, 2017 at 5:46am — No Comments
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…
Added by John Robinson on January 13, 2017 at 5:17am — No Comments
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 standards that govern risk management and lay out regulations and guidelines…Continue
Added by John Robinson on January 13, 2017 at 4:30am — No Comments
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 through the regulatory maze! The regulatory filing requirements for medical devices in Japan are…Continue
Added by John Robinson on January 12, 2017 at 4:51am — No Comments
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, numerous eye-opening statistics have been gathered in recent years to…Continue
Added by Alex on January 11, 2017 at 11:04am — No Comments
Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of…Continue
Added by John Robinson on January 11, 2017 at 5:01am — No Comments
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 Information (PHI) in general, the HIPAA Security Rule (SR) concerns itself…Continue
Added by John Robinson on January 10, 2017 at 4:41am — No Comments
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…Continue
Added by John Robinson on January 9, 2017 at 6:42am — No Comments
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 regulatory bodies. The aim of GMP compliance for a pharmaceutical laboratory is to ensure…Continue
Added by John Robinson on January 9, 2017 at 6:00am — No Comments