One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other terminologies and concepts that need to be applied for an effective calibration program, but are not found in the regulation, such as instrument classifications, also need to be taken into consideration.…
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Added by Adam Fleming on October 9, 2017 at 6:16am —
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[Illustration: Aelitta/istockphoto]
What if your employer asked you to implant a microchip under your skin to help them keep track of you?
Three Square Market…
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Added by John Robinson on October 4, 2017 at 6:41am —
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Tobacco, an age-old addiction, dishes out some chilling, unpleasant facts. Tobacco is the US’ leading cause of preventable deaths. Between four and five percent of the entire American population -some 16…
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Added by John Robinson on September 22, 2017 at 6:16am —
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An internal audit, as we all know, is carried out for a number of specific purposes, the main one among which is to assess the adherence to the industry guidelines for quality and processes. Helping the organization meet the requirements of processes and standards, which are usually issued by regulatory agencies and other relevant bodies and boards, is the main aim…
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Added by Adam Fleming on September 4, 2017 at 5:36am —
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The General Data Protection Regulation (GDPR), which has been codified as Regulation (EU) 2016/679, is a very powerful law regarding the protection of data of the half billion people who live in the European Union (EU). Having come into effect as a result of the European Commission having adapted the proposal for its creation on January 25, 2012; it will replace Directive…
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Added by Adam Fleming on August 16, 2017 at 5:32am —
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In any industry, compliance is everything; be it highly specialized fields such as the life sciences, healthcare, medical devices or non-technological areas such as food and clothing. Why do companies need to be compliant? It is simply because being in compliance with the required regulatory requirements helps the organization to achieve the most positive outcomes needed for a business:
- It earns them a good reputation
- Increases stakeholder and customer…
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Added by Adam Fleming on August 3, 2017 at 5:48am —
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Most healthcare providers or organizations that are described as Covered Entities by HIPAA, engage vendors as HIPAA Business Associates for carrying out many of their services on their behalf. HIPAA defines a Business Associate as a person or an entity who carries out some or all functions or activities that involve the use or disclosure of Protected Health Information on behalf of, or of providing services to a…
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Added by Roger Steven on August 2, 2017 at 8:13am —
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It is said that a picture is worth a thousand words. This adage may appear figurative and allegorical when applied to the realm of statistics, but there is no denying the fact that a visual approach to statistics enlivens the subject like no other. A dash of pictorial work and some coloring at the right places enhance the…
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Added by John Robinson on August 1, 2017 at 6:03am —
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A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA are…
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Added by John Robinson on July 31, 2017 at 6:28am —
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Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971.
You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous…
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Added by Adam Fleming on July 19, 2017 at 5:47am —
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The fact of about 120 million individuals being affected by HIPAA breaches in 2015 highlights two important points:
- There is a mad demand for these records in the black market, which is why they are being targeted to this extent. Any wonder that PHI is in greater demand in the black market than even social security and credit cards?
- There…
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Added by Roger Steven on July 14, 2017 at 8:05am —
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Overview of this session Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.
You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective…
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Added by Adam Fleming on July 13, 2017 at 5:43am —
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When people with autism spectrum disorder (ASD) –called just autism –enter college, they are up against challenges that are unique and peculiar to the group. They need to be understood for their special needs, because they enter college at a sensitive age. There is an onus on the part of the other people in the college, such as peer students and staff and those in…
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Added by Roger Steven on July 12, 2017 at 7:43am —
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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.…
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Added by Adam Fleming on July 12, 2017 at 5:23am —
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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.…
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Added by Adam Fleming on June 14, 2017 at 6:09am —
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Added by John Robinson on June 5, 2017 at 7:26am —
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Added by John Robinson on May 25, 2017 at 5:39am —
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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…
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Added by Adam Fleming on May 22, 2017 at 7:53am —
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Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and…
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Added by Adam Fleming on May 19, 2017 at 6:17am —
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Technology transfer is a process that has gained widespread acceptance and prominence in many areas of knowledge all over the world today. Technology transfer can be broadly defined as the way in which technology is transferred from the source of its origin of creation to sources from where it can be developed and/or distributed to a wider area.
Technology transfer is carried out in a number of…
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Added by Adam Fleming on May 10, 2017 at 6:41am —
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