A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?
Harmonization
Why Perform a Gap Analysis?
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Smartphone-Enabled COVID-19 Test
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Pharmaceutical Temperature Mapping
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The USMCA Agreement
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Application of Harmonized Vs Latest Version of Standards
Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the...
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