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November 2016 Blog Posts (25)

Ways of Carrying out HPLC Analytical Method Development and Validation

In the field of pharmaceuticals, instrumental liquid chromatography is an analysis widely used to determine purity, the impurities, and the degradation of products. The Standard Operating Procedure (SOP) is the area on which most validation work is focused. However, auditors look for other areas, such as validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals.…

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Added by Adam Fleming on November 4, 2016 at 5:57am — No Comments

Mitigating the pain of an RFP process

Utmost care has to go into a financial institution’s Cash Management and credit RFP process, which is quite a painful process. One needs to think about the whole process and get a thorough understanding of it before entering this exercise.  This understanding will go a long way in helping to ease the pain of the process, but is in itself quite an exercise.

A clear understanding…

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Added by Adam Fleming on November 3, 2016 at 6:14am — No Comments

The OCR’s Phase 2 Audit Program

The Office for Civil Rights (OCR) newly released the Phase 2 Audit Program. The audit process has started with the release of the rules and protocols. The need for a clear understanding of this new audit program by all Covered Entities (CE) and Business Associates (BA), or for that matter anyone who accesses, uses or discloses Protected Health Information (PHI) is…

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Added by Roger Steven on November 3, 2016 at 5:58am — No Comments

Risk of omission is a critical one in Quality

Omission is a very important, but often overlooked aspect of Quality. It is often not realized in most organizations that the risk not doing a thing right, or what may be termed risk of omission, usually outweighs and is far more dangerous than the risk of what they do wrong, or what is a result of poor quality. The best way to understand the importance of this paradigm is that poor quality generally comes out or makes itself known during inspections and tests, or when…

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Added by Adam Fleming on November 2, 2016 at 6:12am — No Comments

Understanding how to implement the OSHA’s new rule on silica dust

Exposure to silica dust is a serious health hazard for those in construction workers and related jobs. This can result in life long disease or even death due to lung cancer. The Occupational Safety and Health Administration (OSHA) has a new regulation that deals with what employers need to do in order to prevent and offset the damage caused by extensive exposure to…

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Added by Roger Steven on November 2, 2016 at 5:49am — No Comments

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