Category Archives: Uncategorized

25Aug/15
Image Courtesy of Forbes

Intelligence Based E-Inspections

By Daniel R. Matlis, President, Axendia

Are You Ready to be Graded on a Curve?

Summary

The Food and Drug Administration Safety and Innovation Act (FDASIA) provided the agency with sweeping new statutory authorities, which have not garnered much attention by industry.  A key FDASIA provision is the ability to conduct electronic inspections (e-Inspections) and target onsite inspection based on metrics.

By shifting to a metrics based approach the Agency seeks to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.

“…we want to encourage firms to prioritize quality and encourage their boardrooms and their pocketbooks because quality costs money,” stated Howard Sklamberg, J.D., FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

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11Aug/14
CFQ 2

FDA Forum Fosters Candid Discussion Between Industry and Agency

By Daniel R. Matlis

On June 26, the FDA hosted an Executive Forum on the “Case for Quality Initiative.” The forum brought together Industry Executives, FDA Officials and Industry Advisors in a series of roundtable discussions and presentations.

After the event, I had the opportunity to converse with two FDA Officials to gain their perspectives on the forum.

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