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Blog & Updates

January 23, 2015

Fundamental of the Week

Hello Everyone! Happy TGIF! Here is the Fundamental of the week: “Speak straight. Speak honestly in a way that forwards what we are up to. Make clear and direct requests. Be willing to surface ideas or take positions that may result in conflict when it’s necessary to reach our objectives.” It is very important for […]

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As a result of a new regulation issued by the Food and Drug Administration, device manufacturers will be required to have a unique identifier for any device that they wish to market in the United States. The law is already in effect for many Class III devices, and more devices will be required to have […]

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January 16, 2015

Fundamental of the Week

Happy TGIF! Here is the Fundamental of the week: “Listen generously. Learn to listen for the contribution in each other’s speaking versus listening from our assessment, opinions, and judgments.” This is a very good Fundamental and it brings to mind the idea of innovation. Many times we look for reasons not to do something instead […]

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January 16, 2015

What is Part 11?

With the increased use of electronic submissions and documents in electronic format, pharmaceutical companies should understand the regulations that pertain to them. Twenty-one Code of Federal Regulations Part 11 is the section that deals with the use of electronic records, electronic signatures, and handwritten signatures committed to electronic format. It consists of Subparts A, B, […]

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The FDA has tackled the issue of quality control problems in the pharma sector. According to Reuters: “Dr. Janet Woodcock, head of the FDA’s pharmaceuticals division, said at a news conference that the project, some 10 years in the making, is designed to establish consistent quality standards for all drugs, whether brand name or generic. […]

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