FDA Warning Letter And 483 Observation Trends

Posted on 01. Dec, 2016 by .

One way the Food and Drug Administration provides feedback and guidance, as well as enforcement of current regulations, to manufacturers and associated industry groups is through the inspection process. The evidence of an inspection is documented and communicated in heightening levels of severity from the close out meeting, FDA 483 forms to an official Warning [...]

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Elements of Microlearning

Posted on 28. Nov, 2016 by .

Microlearning, which is a way of delivering content to learners in small, very specific bursts over time or as needed, has become important from a learning and development perspective for a number of reasons. Short Time Bursts—The short time bursts needed for microlearning means that the learning can occur at various times without pulling a [...]

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The Art of Effective CAPA and Follow-Through

Posted on 24. Nov, 2016 by .

As professionals in a well-regulated industry, we have been hammered over the head with the old adages “Don’t make promises you can’t keep, It’s not the quantity but the quality that matters, Do it right, do it once…” What if deviations occur? How can we ensure that corrective actions work? What is the best way [...]

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Mylan and Others in the News but Congress Unlikely to Act

Posted on 21. Nov, 2016 by .

It seems that everywhere you turn there is news of exceedingly high drug prices and possible abuses of the public trust. Bloomberg News recently reported that the Centers for Medicare and Medicaid Services have indicated that the EpiPen manufacturing company Mylan NV has “for years overcharged the U.S. Medicaid health program to buy its EpiPen [...]

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Management Reviews: Sample Checklist

Posted on 17. Nov, 2016 by .

Management responsibility is the cornerstone of any Quality System, according to the US Food and Drug Administration (FDA) and international quality standards. The most sophisticated and compliant Quality System will not remain that way without vigorous and continuous management review and support. And unlike other duties, management cannot delegate its responsibility for quality. US FDA [...]

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FDA Research and Development in the Digital Age

Posted on 14. Nov, 2016 by .

The FDA has jumped into the digital age with both feet in 2015 by launching the online research portal precisionFDA. This portal was developed by FDA scientists with the help of leading minds from Silicon Valley as part of President Obama’s Precision Medicine Initiative (PMI). As the FDA indicates: The goal of the PMI is [...]

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QC Lab Control Requirements

Posted on 10. Nov, 2016 by .

All laboratory analysts must follow cGMPs in order to create effective products and comply with all quality standards. In this article, we focus on five analytical laboratory practices, which are covered in our course, Application of cGMPs to Analytical Laboratories (PHDV78), which is reviewed by the experts at Raland Compliance Partners. Handling and Identifying Reagents [...]

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Smaller Chunks of Content Lead to Big Learning

Posted on 07. Nov, 2016 by .

Most of us have crammed for an exam or two in our lives. We’ve stayed up all night studying material we should have been studying all semester. And, it turns out, most of us did well on the test. We retained the information well enough to be successful the next day. The problem is that [...]

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