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Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line
The “CY2016 Annual FDA Medical Device Quality System Data” report is an information goldmine for devicemakers — a key to better inspection outcomes as well as greater quality in manufacturing.
In its pages you’ll discover hot-off-the-press aggregate data on inspections, Form 483 observations and warning letter citations that you can use to increase quality in manufacturing and compliance.
Sadly, not enough devicemakers know how to get the most out of this valuable annual report from the CDRH.
But Michael Gaba, Cisco Vicenty and Daniel Walter do. And they’re about to show you.
Mr. Gaba — an attorney with Polsinelli LLP — Mr. Vicenty — the Program Manager for the Case for Quality within the Office of Compliance at FDA’s Center for Devices and Radiological Health — and Mr. Walter — Chief, Foreign Enforcement Branch, Division of International Compliance Operations, Office of Compliance, CDRH — will help you get better inspection outcomes, boost manufacturing quality, and avoid FDA sanctions.
Participants will discover:
Meet Your Presenters
Daniel Walter is currently the Chief of the Foreign Enforcement Branch in the Division of International Compliance Operations within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. The branch oversees the compliance efforts for medical device manufacturers outside the United States, and includes inspection review, recall classification, and administration of allegation of regulatory misconduct, as well as assisting the office, Center, and Agency for cross-cutting initiatives.
Daniel began his career at FDA as a compliance officer in, then was promoted to the branch chief of, the Vascular and Circulatory Support Branch in the Office of Compliance at CDRH. He is a member of FDA’s Device Curriculum Committee, and is collaborating with the Division of Cardiovascular Devices in ODE and cardiovascular analysts in OSB to develop cross-cutting mechanisms to enhance patient outcomes through information sharing.
Prior to working with FDA, Daniel Walter was a Validation Engineer for several companies, leading to becoming the Director of Quality at DST Controls. Daniel’s experience includes facility, utility, equipment, and process validations for automated and non-automated systems, including for steam and compressed air distribution validations, cleaning validations, self-contained automated manufacturing lines for liquid and solid pharmaceutical manufacturers.
Cisco Vicenty is currently the Program Manager for the Case for Quality (CfQ) within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. This effort is part of the CDRH strategic priorities for 2016 and 2017. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients in order to increase focus on the quality and performance of medical devices.
Cisco began his career at FDA as a compliance officer in the Cardiac Rhythm and Electrophysiology Branch in the Office of Compliance at CDRH. He then worked as a project manager for the FDA’s Case for Quality initiative. Cisco is currently the permanent Chief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality, within the Office of Compliance.
Prior to working with FDA, Cisco Vicenty was a Quality and Reliability Engineer with the Micro-Electronics Business Unit at IBM responsible for emerging server technology lines and network systems along with high volume gaming systems from Nintendo, Sony, and Microsoft.
Michael Gaba provides strategic FDA regulatory, Medicare reimbursement, and public policy counsel to medical device and biotech companies. His primary goal is to bring companies to market and then help them remain there in the most efficient, effective manner possible.
Working as an extension of each company’s legal and business teams, Michael draws on a 20+ year history to navigate the FDA pre-market regulatory pathways, counsel companies on FDA post-market compliance matters, and resolve Medicare coverage, coding, and reimbursement disputes with the Centers for Medicare and Medicaid Services. By using his FDA and CMS experience during the product development phase, Michael is able to help maximize companies’ opportunities to be appropriately compensated in the proper treatment venues, whether it's the physician's office, the hospital outpatient department or home care.
Recognizing that there are times when federally-regulated life science companies would benefit from changes to public policy, Michael works with members of Congress and Executive Branch officials to help modify or create the necessary policies that not only redound to the benefit of life science companies, but also to the patients they serve.
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