13th Annual FDA Inspections Summit Presentations

 

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PRE-CONFERENCE WORKSHOPS – Tuesday, Oct. 23, 2018

Drugs & Biologics Preconference Workshop

1:00 p.m. – 5:00 p.m.
Flawless FDA Inspection Handling and Response

  • John Avellanet, Managing Director and Principal, Cerulean Associates LLC

Medical Devices Preconference Workshop

1:00 p.m. – 5:00 p.m.
Preparing Your Team for EU-MDR

  • Dan O’Leary, President, Ombu Enterprises, LLC

Clinical Trials Preconference Workshop

1:00 p.m. – 5:00 p.m.
ICH E6 (R2) How to Build a Sponsor Risk Management Program

  • Susan Leister, Director-QA, Technical Resources International

 

DAY ONE – Wednesday, Oct. 24, 2018

9:10 a.m. – 10:00 a.m.
Why "Quality" Doesn't Matter

  • Marla A. Phillips, Ph.D., Director, Xavier Health, Xavier University; former Head of Quality at Merck’s North Carolina facility

10:00 a.m. – 10:45 a.m.
Good Supply Practices (GSPs) for the Lifesciences

  • Marla A. Phillips, Ph.D., Director, Xavier Health, Xavier University; former Head of Quality at Merck’s North Carolina facility

 

Drugs & Biologics Track

11:10 a.m. – 12:00 p.m.
The US/EU Mutual Recognition of Drug GMP Inspections (No slides for this session)

  • Ellen Morrison, Associate Commissioner, OMPTO, ORA, FDA

12:00 p.m. – 12:45 p.m.
The FDA’s New Approach to Drug Inspections

  • Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health; former Director of the Office of Compliance, CDER, FDA

1:45 p.m. – 3:15 p.m.
Panel Discussion: Global Data Integrity (No slides for this session)

Moderator:

  • Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates, Inc.

Panelists:

  • Kalah Auchincloss, J.D., Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health
  • Ronald Tetzlaff, PhD, Corporate Vice President, PAREXEL Consulting
  • John Avellanet, Managing Director and Principal, Cerulean Associates LLC

 

Medical Devices Track

11:10 a.m. – 12:00 p.m.
Getting to Root Cause During Your CAPA Investigation

  • Karl Vahey, Vice President Manufacturing Quality, Cardinal Health

12:00 p.m. – 12:45 p.m.
The MDSAP Process

  • Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF Health Sciences

1:45 p.m. – 3:15 p.m.
Panel Discussion: MDSAP Audit Experience

Moderator:

  • 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

Panelists:

  • Marc-Henri Winter, Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA
  • Alexander Crosby, Americas Program Manager, Medical Devices, Business Assurance, Intertek
  • Maura Corcoran, Senior Director, Quality Operations, Ethicon Wound Closure Repair (JnJ)
  • Karl Vahey, Vice President Manufacturing Quality, Cardinal Health
  • Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF Health Sciences

 

Clinical Trials Track

11:10 a.m. – 12:00 p.m.
BIMO Update

  • David Glasgow, Deputy Program Director, Office of Bioresearch Monitoring Operations, OMPTO, ORA, FDA

12:00 p.m. – 12:45 p.m.
Using Metrics to Achieve Inspectional Readiness

  • Linda Sullivan, Executive Director, Metrics Champion Consortium

1:45 p.m. – 3:15 p.m.
Panel Discussion: The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site

Moderator:

  • David Borasky, Vice President IRB Compliance, WIRB-Copernicus Group

Panelists:

  • David Glasgow, Deputy Program Director, Office of Bioresearch Monitoring Operations, OMPTO, ORA, FDA
  • Phillip Leese, President, Medical Consultants PA
  • Cassandra Kennedy, VP, Global Head, Regulatory Compliance and Quality Assurance, Covance

 

PLENARY SESSION

3:30 p.m. – 4:15 p.m.
How FDA’s New Inspection Protocol Helps Ferret Out Data Integrity Issues

  • John Avellanet, Managing Director and Principal, Cerulean Associates LLC

4:15 p.m. – 5:00 p.m.
Midterm Assessment and Outlook: A Look at Gottlieb’s FDA and What Lies Ahead

  • Marc Scheineson, Partner, Alston & Bird LLP

 

DAY TWO – Thursday, Oct. 25, 2018

9:10 a.m. – 10:00 a.m.
Ethical and Scientific Issues in Developing Deep Learning Systems in Medicine: More Like Drugs Than You Might Think

  • Alex John London, Clara L. West Professor of Ethics and Philosophy and Director of the Center for Ethics and Policy, Carnegie Mellon University

10:00 a.m. – 10:45 a.m.
Total Cost of Quality and Industry 4.0: The Bi-Modal Challenge Facing Quality Leaders Today

  • Steve McCarthy, Vice President of Digital Innovation, Sparta Systems; former VP of Quality Systems Shared Services, Johnson & Johnson

11:00 a.m. – 12:00 p.m.
Panel Discussion: How to Manage a Combination Products Inspection (No slides for this session)

Moderator:

  • Quynh Hoang, Consultant, FDA and Life Sciences, King & Spalding

Panelists:

  • Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson
  • David Shore, Quality Director, IDM, Eli Lilly and Company
  • Anita Michael, Principal Consultant, PAREXEL Consulting