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 Speaker Profile

Albert Cefalo
Regulatory Affairs Specialist, Analogic Corporation

Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved in all activities related to Quality Assurance and Regulatory Affairs such as Creation and maintenance of SOPs, FDA, Health Canada and CCC submissions as well as served as Director of quality for several of Analogic's Business Units. Chuck also conducts in-house training on a variety of subjects. Chuck is the Regulatory Affairs representative on all of the Analogic Project Teams and provides an oversight of the Risk Management process.

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Webinar on Specification Mapping

In order for an organization to satisfy the requirements for Design Control, no matter what Quality Management System (QMS) is being followed, there needs to be traceability from the Product Requirement specification through the verification and validatio

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The FDA Electronic Submission Gateway (ESG)

With the upcoming mandate by the FDA of the use of their Electronic Medical Device Reporting System (eMDR) all medical device manufacturers will be required to create and submit MDRs via the FDA's Electronic Submission Gateway or FDA ESG.

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