Airport Traffic Control Tower

Airport Traffic Control Tower

Aircraft that move through controlled airspace need direction and clarity to avoid collisions. Airport traffic control is the system used for regulating this and guiding pilots to safety. This system, by which air traffic is regulated and organized, is called air traffic control. It is primarily carried out using an airport traffic control tower through visual observation.

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HACCP Plans

HACCP Plans

HACCP has listed 12 tasks for preparing an HACCP plan. These include establishing an HACCP team, describing the product, identifying its intended use, drawing up the commodity flow program, confirming it onsite, and using the seven principles listed by HACCP for identifying and analyzing a hazard. These seven principles need to be implemented in a detailed, step-by-step manner.

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Dr. Reddy’s Labs (RDY) Sinks Lower Following FDA Warning Letter

Dr. Reddy’s Labs (RDY) Sinks Lower Following FDA Warning Letter

Dr. Reddy’s Laboratories, an India-based manufacturer and exporter of bulk generics, has been issued a Warning Letter by the FDA in November, 2015. The FDA says this warning was because it discovered a quality control lab in the company that it had not known earlier. This caused Dr. Reddy’s shares to plunge by about 4 percent in the trading market.

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Global Life Sciences Companies Choose FDA Investigation Training

Global Life Sciences Companies Choose FDA Investigation Training

Global life sciences companies are choosing to undergo FDA investigation training with the main intention of being able to tackle an FDA investigation. It is for identifying compliance risks, learning ways of mitigating before during and after inspections, anticipating and replying to 483’s, evaluating the ability of the quality systems to meet FDA expectations and so on.

 

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The Design Controls + Risk Management Connection

Design controls are related to risk management in a number of ways, from all the three standpoints: verification, validation and risk controls. These should flow seamlessly into each other to complete the safety management system of medical devices. Design controls should sit with design inputs and outputs and verification and validation of design, and should be tied to risk controls.

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How the ISO 9001:2015 Revision Affects Medical Device Companies

How the ISO 9001-2015 Revision Affects Medical Device Companies

The ISO 9001:2015 is set to be the most far-reaching change brought about to the ISO 9000 series standards since 2000. The most discernible change that medical device companies have to adopt is that they will now be taking a process management approach rather than a checklist approach for inspecting the final product.

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Electronic Health Record Challenges

Electronic Health Record Challenges

Electronic Health Records (EHRs) give rise to many challenges. Some of these are poor user interface, inability to facilitate easy toggle between different menus, difficulty in migrating from an EHR created by one company to that of another, absence of a voice format for enabling dictation, and difficulty in reading the charts.

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