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FDA 21 CFR -Part 821 Medical Device Tracking Requirements –

The device should be intended to be implanted in the human body for over a year.
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Why should organizations ensure FDA 21 CFR Part 11 Compliance? –

Why should organizations ensure FDA 21 CFR Part 11 Compliance? – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
Electronic signatures and records have to be authentic to the extent of being considered as being equivalent to actual, paper records.
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Facebook’s data scandal should be a wake-up call about our online footprint –

Facebook’s data scandal should be a wake-up call about our online footprint – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
The Facebook episode should be a wake-up call for people when it comes to learning about the information out there about them.
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Financial institutions to publish bank-specific cyber security policies –

Financial institutions to publish bank-specific cyber security policies – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
Security guidelines to protect consumers and create a safer environment for online and e-payments products.
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Australian government considers approach to cybersecurity –

You talk to other countries and we have a chance here to lead the world.
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Millions Of Americans Binge-Drink Regularly –

If you’re recovering from St. Patrick’s Day festivities, the results of a new study from the CDC may make you think twice about doing it again. The paper finds that people in the U.S. consume over 17 billion drinks per year during binges—that is, excluding all the regular drinking that people do. Although other substances, like opioids,…
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The EU’s Pharmacovigilance Directive –

The EU’s Pharmacovigilance Directive – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
The Pharmacovigilance Directive underwent a major revision in 2010, by which a new legislation came into effect.
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Trump gets gift from Russia panel –

Trump gets gift from Russia panel – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
I think this will reignite those who want to take out Mueller after they were undercut in the wake of those indictments.
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Statement from FDA Commissioner Scott Gottlieb, M.D., –

Statement from FDA Commissioner Scott Gottlieb, M.D., – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
The FDA takes concerns about Essure very seriously.
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Deaths in Dundalk –

Deaths in Dundalk – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
Predeceased by his brothers John and Timmy and nephew Denny.
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49-day Hack shows need for cyber security beef up

At that point the agency had found out that about 200 email accounts were under the control of criminals.
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21 health benefits of napping

The researchers say your brain’s ability to go into a tranquil state during sleep is linked to your ability to remember.
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AB Foods says first-half profit held back by sugar​

AB Foods says first-half profit held back by sugar​ | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
Total first half sales at Primark, the fashion chain which accounts for about half of group revenue and profit.
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PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001 –

We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001
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Robots may have role in future of elder care –

Robots may have role in future of elder care – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
More people live alone these days, and a robot can be a conversation partner for them.
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How to understand the Pharmaceutical Regulatory Affairs –

How to understand the Pharmaceutical Regulatory Affairs – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
The important point to note about Pharmaceutical Regulatory Affairs is that it deals with every stage of production.
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Virtual healthcare has to be understood and used for what it can offer –

Virtual healthcare has to be understood and used for what it can offer – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
Virtual healthcare can be seen as a natural extension of these uses of technology.
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Good Documentation Practices Relating to USP –

Good Documentation Practices Relating to USP – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
The General Chapter explains the justification for putting in place Good Documentation Practices in USP and helps the user evaluate and construct GMP activities.
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Suddenly it happens in Florida –

Suddenly it happens in Florida – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
The Florida Highway Patrol previously said several people were killed but did not release a figure on fatalities.
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Stephen Hawking’s secret to surviving his terrible condition –

Stephen Hawking’s secret to surviving his terrible condition – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
Hawking replied from his wheelchair, his lips bending up into a slight smile. “And also a universe where you’re funny.
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Pharmaceutical Water Systems have to be Designed with a Lot of Common Sense –

Pharmaceutical Water Systems have to be Designed with a Lot of Common Sense – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
Working in tandem with Quality Assurance allows approval of use after installation and subsequent maintenance.
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ICH Q10 -the ICH’s Pharmaceutical Quality System –

ICH Q10 -the ICH’s Pharmaceutical Quality System – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
Related to the Quality area; these guidelines include crucial milestones such as doing stability studies.
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When coliform bacteria are detected in drinking water –

When coliform bacteria are detected in drinking water – | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
The feces of humans as well as other warm-blooded animals are a source of these bacteria. Coliforms are primarily used as a method for indicating water quality.
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FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter

FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
The FDA's Bioresearch Monitoring Program has a few functions, which research organizations that have to survive an FDA inspection could do well to comprehend.
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When a medical device fails to meet these standards for precision and accuracy

When a medical device fails to meet these standards for precision and accuracy | Online Information Technology Trainings, Project Management, Computer Architecture and System Integration - compliance4All | Scoop.it
In the absence of any of these; the company has to form its own set of standards for meeting medical device calibration requirements.
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