The Cutting Edge of Medical Technology Content, Community & Collaboration
Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual,…
Added by John Robinson on July 12, 2017 at 6:21am — No Comments
Letters of Credit are the primary instruments for assuring payment of goods sold internationally. This web session is designed to provide attendees with an end-to-end understanding of the L/C (letter of credit) process. From the beginning of a contractual agreement, through the letter of credit application process and actual negotiation of the L/C, this information-rich webinar will provide techniques that are indispensable to both importers and exporters.…
Added by Adam Fleming on July 12, 2017 at 5:23am — No Comments
Healthcare professionals have to mandatorily carry out HIPAA audits in a way that satisfies the regulatory authorities. This needs a thorough understanding of the exact meaning and import of words contained in HIPAA. They also need to get a grasp of the purpose and intent conveyed in HIPAA’s language. This is absolutely essential for both the…
Added by John Robinson on July 7, 2017 at 6:09am — No Comments
Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each…
Added by John Robinson on June 28, 2017 at 6:15am — No Comments
Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.
There is a misconception that they are similar to or are the same as generics, but this is not so in…
Added by John Robinson on June 27, 2017 at 6:01am — No Comments
Added by John Robinson on June 14, 2017 at 6:28am — No Comments
Food, despite being the most important human need, is fraught with many risks and hazards. The food chain, which consists of activities that cover everything from the proverbial farm to fork, passes through many points at which a harm of any nature can happen. The chances of risks to the food safety chain are all the more amplified in this age of globalization, when food travels through many regions and continents from its source to its destination.…
Added by Adam Fleming on June 14, 2017 at 6:09am — No Comments
It is not commonly known that a Covered Entity or its Business Associate have to comply with HIPAA regulations that relate to their organization’s human resources function. While HIPAA requirements for departments that deal with IT security…
ContinueAdded by Roger Steven on June 12, 2017 at 8:31am — No Comments
Added by John Robinson on June 5, 2017 at 7:26am — No Comments
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…
Added by Adam Fleming on May 24, 2017 at 6:31am — No Comments
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…
Added by Adam Fleming on May 22, 2017 at 7:53am — No Comments
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…
ContinueAdded by John Robinson on May 19, 2017 at 5:52am — No Comments
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…
Added by Adam Fleming on May 17, 2017 at 6:40am — No Comments
Added by John Robinson on May 17, 2017 at 5:57am — No Comments
The FDA has strict requirements on the way promotion and advertising practices are to be implemented by the industries that it regulates. Section 906 of the Food and Drug Administration Amendments Act (FDAAA), which came into effect in 2008 and amended the section that pertained to this topic previously, namely Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA); now requires that published Direct to Consumer (DTC) advertisements for prescription drugs should…
Added by Adam Fleming on May 11, 2017 at 6:23am — No Comments
There is the saying that after all is said and done, to err is human. In a philosophical sense, it can have numerous interpretations, but in the field of Good Manufacturing Practice, it cannot be taken with a pinch of fatalism. GMP requires everything to be precise and scientific to a T. GMP is not an area that leaves anything to human error. Being an area of science, GMP has no place for imagination and chance.…
Added by Adam Fleming on May 8, 2017 at 7:48am — No Comments
Professionals in a wide number of industries and businesses find the VLOOKUP function in Excel very useful. Why this is so is that it helps in locating an exact value. Using VLOOKUP, an MS Excel user can find a specific piece of information in the spreadsheet. This is very useful when there are very many values in a grid. In other words, the VLOOKUP…
Added by Adam Fleming on May 4, 2017 at 6:14am — No Comments
Added by John Robinson on April 25, 2017 at 6:18am — No Comments
Added by John Robinson on April 17, 2017 at 5:49am — No Comments
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 because engineers and other non-biologists also need this training if they are involved with any aspect of water…
ContinueAdded by John Robinson on January 31, 2017 at 5:09am — No Comments
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