The FDA Electronic Submission Gateway (ESG)

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

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The FDA Electronic Submission Gateway (ESG)

The FDA Electronic Submission Gateway (ESG)

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Instructor : Albert Cefalo

Product Id : 600122

Overview: 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.

The long and tedious task of making this connection to the gateway has many steps and takes a considerable amount of time between steps to complete the process. The connection process begins with a series of paperwork/letters which must be provided, through the set up of the Test System Gateway, to the sending of a large file (7G) across the gateway to the final step of achieving access to the Production Gateway. This one hour session will provide an overview of the specific steps require to complete a successful connection to the FDA ESG. Whether you are the IT professional or the QA, RA or Engineer who will be responsible for this action, this webinar will be instrumental in providing you with the insight to complete the task.

Areas Covered in the Session:

Process of Obtaining FDA ESG Access
Test Gateway
Production Gateway
What Can Be Sent Across the ESG

Who Will Benefit:

Design Engineers
Quality Assurance Personnel
Program Managers
Manufacturing Engineers
Regulatory Personnel
Engineering Managers
Product Group Managers
IT Managers

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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