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The Cancer Moonshot Summit

In my previous blog, I discussed the announcement of Vice President’s, Joe Biden, cancer “moonshot.” After six months from the launch of the government's moonshot, the United States has not yet doubled the rate of progress toward finding a cure as had hoped yet, there...

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The FDA’s New Draft Guidance

More recently, the FDA has begun seeing data integrity as a major concern to the violations discovered during audits. As a result, the FDA published its new draft guidance, Data Integrity and Compliance with cGMP, in April 2016 with the purpose to provide...

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Departmental Roles of Data Integrity

Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data integrity is influenced by everyone at an organization. As a result, it is essential that employees at all levels understand...

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