Annual Medical Device Quality Congress Presentations

MDQC 2018

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Tuesday, April 3, 2018PRE-CONFERENCE WORKSHOP

8:30 a.m. – 12:00 p.m.

Effective Complaint Management

Dan O’Leary, President, Ombu Enterprises LLC

 

Tuesday, April 3, 2018DAY 1

1:15 p.m. – 2:00 p.m.

Enacting the Case for Quality: Defining Metrics

  • Francisco Vicenty, Program Manager for the Case for Quality, Office of Compliance, CDRH, FDA

2:00 p.m. – 2: 45 p.m.

ISO 13485:2016 – Starting The Final Countdown

  • Robert Ruff, Executive Director of Medical Device Education and Training, NSF Health Sciences; former Medical Device Specialist and Senior Investigator at ORA and International Team Lead at CDRH, FDA

3:00 p.m. – 4:30 p.m.

Panel Discussion: Voluntary Medical Device Manufacturing and Product Quality Program

Moderator:

Stephanie Christopher, Program Director, CfQ & PCBR, MDIC

Panelists:

  • Francisco Vicenty, Program Manager for the Case for Quality, Office of Compliance, CDRH, FDA
  • Al Crouse, Sr. Quality Director, CVRx Inc.
  • Joseph Sapiente, Vice President, Quality and Regulatory Affairs, Surgical, Breast Health and Skeletal, Hologic

4:35 p.m. – 5:20 p.m.

Preparing for the MDSAP Audit Process: A Case Study from the Manufacturer’s Perspective

  • Connie Hoy, Executive Vice President of RA/QA, Cynosure (RETD.)

 

Wednesday, April 4, 2018DAY 2

9:00 a.m. – 9:45 a.m.

Meet NEST: Building a National Medical Device Surveillance System

  • Gregory Pappas, M.D., Ph.D., Associate Director for National Devices Surveillance, Office of Surveillance and Biometrics, CDRH, FDA

9:45 a.m. – 10:30 a.m.

Keeping Your Quality System Trim: Lean Principles for GMPs 

  • James Shore, President, Quality Lean Solutions

10:45 a.m. – 12:15 p.m.

Panel Discussion: European Medical Device Regulations — Preparing for the Storm

Moderator: Maria Fagan, President, Regulatory and Quality Solutions (R&Q)

Panelists:

  • Robert Ruff, Executive Director of Medical Device Education and Training, NSF Health Sciences; former Medical Device Specialist and Senior Investigator at ORA and International Team Lead at CDRH, FDA
  • Dan O’Leary, President, Ombu Enterprises LLC
  • Karl Vahey, Vice President Manufacturing Quality, Cardinal Health
  • Ibim Tariah, Technical Director, BSI Americas Inc.

1:15 p.m. – 2:00 p.m.

FDA Reauthorization Act of 2017 (FDARA)

Jessica Ringel, Counsel, FDA and Life Sciences, King & Spalding LLP

2:00 p.m. – 2:45 p.m.

FDA’s Focus on Risk Management and Cybersecurity for Devices that Contain Software

Seth Carmody, Staff Fellow, Office of the Center Director, CDRH, FDA

3:00 p.m. – 4:30 p.m.

Panel Discussion: MEDDEV 2.7/1 revision 4 and Clinical Evaluation Reporting (CER) 

Moderator: Carol Ryerson, Sr. Principal Advisor, Regulator Affairs, RCRI

Panelists:

  • Dr. Jonathan Gimbel, Director of Western Pennsylvania Operations, Regulatory and Quality Solutions (R&Q)
  • Mary Beth Henderson, VP Regulatory Affairs and Quality Systems and Sr. Principal Advisor, RCRI
  • Ibim Tariah, Technical Director, BSI Americas Inc.

 

 

Thursday, April 5, 2018POST-CONFERENCE TRAINING

8:30 a.m. – 5:30 p.m.

Post-market Surveillance

  • Dan O’Leary, President, Ombu Enterprises LLC