QUOTED. Sept. 25, 2018. Cisco Vicenty.
Executive Summary
US FDA's Voluntary Medical Device Manufacturing and Product Quality Pilot Program has become so popular that both the agency and device-makers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members to assist in appraisals at device firms. See what FDA's Cisco Vicenty said about it here.
"The more we get [our] people accustomed to the terminology, the language, the approach in methodology that we're using for CMMI [Capability Maturity Model Integration], the better it is to integrate and make some of the internal changes we're trying to go through [at FDA]. That's just from a standpoint of our own internal improvements – it's of value. But the additional piece of this is, we've been trying to figure out a way to enable this to be an additional dialogue or an additional resource moving forward. As we have been evaluating the need and scalability of the program, we do need to make sure we have people with the right skillsets, and more of them across the board." –Cisco Vicenty, program manager, Office of Compliance, US FDA's Center for Devices and Radiological Health
- Find out more: FDA Staffers, Device Firm Employees Are Training As Appraisal Team Members For CMMI Maturity Model Pilot
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