Tenth Annual FDA Inspections Summit Presentations


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PRE-CONFERENCE WORKSHOPS
Wednesday, Nov. 4, 2015

1:00 p.m. – 5:00 p.m.
Flawless FDA Inspection Handling and Response
John Avellanet, Managing Director and Principal, Cerulean Associates LLC

1:00 p.m. – 5:00 p.m.
Data Analysis Techniques for Device Manufacturers – Improve Performance to Avoid Warning Letters
Dan O'Leary, President, Ombu Enterprises

 

DAY ONE – Thursday, Nov. 5, 2015

8:45 a.m. – 10:15 a.m.
FDA's Quality Metrics Program — The Latest Developments and How They Impact Risk-Based Inspections:  Panel Discussion

Moderator:
John C. (Jack) Garvey, Principal, Chief Executive Officer, Compliance Architects LLC

Panelists:

  • Karthik Iyer, Acting Branch Chief, Quality Intelligence Branch, OC, OPQ, CDER, FDA
  • Nuala Calnan, PhD, Regulatory Science Research Fellow, Pharmaceutical Regulatory Science Team, School of Chemical & Pharmaceutical Sciences, Dublin Institute of Technology
  • Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA; former Quality Assurance Specialist, Office of New Drug Quality Assessment, CDER, FDA
  • Dina Maines, Managing Consultant, Compliance Architects LLC
  • Louis W. Yu, Ph.D., Executive Vice President, Global Quality & Compliance, Perrigo Company plc
  • Dan O'Leary, President, Ombu Enterprises

10:15 a.m. – 11:00 a.m.
FDA’s Mutual Reliance Initiative With the Europe Union
CDR Helen Y. Saccone, PharmD, Senior Advisor, Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA

 

Drugs & Biologics Track

11:30 a.m. – 12:15 p.m.
Understanding OPQ’s New Inspection and Reporting Plan and Organizational Structure
Dr. Lawrence Yu, Deputy Director, Office Product Quality, CDER, FDA

12:15 p.m. – 1:00 p.m.
Cautionary Tales: Ignore at Your Own Peril
Vicky Stoakes, President, IntegRx, Inc.; former FDA Chemist, ACNA and Investigator, Atlanta District Office Drug Cadre

2:00 p.m. – 3:30 p.m.
Former FDA Investigators Tell All: The 10 Best — and Worst — Things to Do When FDA Staff Are on Site: Panel Discussion

Moderator:
Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations

Panelists:

  • David Chesney, Vice President, Strategic Compliance Services, PAREXEL Consulting
  • Elaine Messa, President, Medical Devices, NSF Health Sciences; former director of the Los Angeles District, FDA
  • Vicky Stoakes, President, IntegRx, Inc.; former FDA Chemist, ACNA and Investigator, Atlanta District Office Drug Cadre

 

Medical Devices Track

11:30 a.m. – 12:15 p.m.
Medical Device Single Audit Program Pilot (MDSAP) In Full Swing
Marc-Henri Winter, Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA

12:15 p.m. – 1:00 p.m.
Unraveling the Mystery of EU Unannounced Audits
Roberta Goode, MSBE, CQE, President and CEO, Goode Compliance International

2:00 p.m. – 3:30 p.m.
Effective Management of Front And Back Inspection Rooms — Secrets You’ve Never Heard and Answers To Questions You’ve Always Wanted To Ask: Panel Discussion (No slides for this session)

Moderator:
Julie Larsen, Senior Partner, Director Inspection Readiness Services, BioTeknica

Panelists:

  • Marc Neubauer, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
  • Phil Pontikos, CSO, National Device Expert, OMPTO, ORA, FDA, Columbus, OH
  • Connie Hoy, Senior VP of Regulatory Affairs, Cynosure

 

PLENARY SESSION PANEL DISCUSSION

3:50 p.m. – 5:15 p.m.
A Day in the Life of FDA’s Field Investigators — Current Field Investigators Explain What They Look For and Why: Panel Discussion

Moderator:
Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations

Panelists:

  • Captain Cynthia Harris, Bioresearch Monitoring Specialist, ORA, FDA, Baltimore District Office
  • Marc Neubauer, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
  • Phil Pontikos, CSO, National Device Expert, OMPTO, ORA, FDA, Columbus, OH

 

DAY TWO – Friday, Nov. 6, 2015

8:45 a.m. – 9:15 a.m.
FDA’s Office of Regulatory Affairs: Enforcement Update
Douglas Stearns, Director, Office of Enforcement and Import Operations, ORA

9:15 a.m. – 10:15 a.m.
Combination Products: Integrating FDA’s New Streamlined Approach
Elaine Messa, President, Medical Devices, NSF Health Sciences; former Director of the Los Angeles District, FDA

10:30 a.m. – 12:00 p.m.
Data Integrity — Is Complacency Putting You at Risk?

Moderator:
Vicky Stoakes, President, IntegRx, Inc.; former FDA Chemist, ACNA and Investigator, Atlanta District Office Drug Cadre

Panelists:

  • John Avellanet, Managing Director & Principal, Cerulean Associates LLC
  • Dr. Beverly Lorell, Senior Medical and Policy Advisor, FDA & Life Sciences Practice Group, King & Spalding
  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
  • David Chesney, Vice President, Strategic Compliance Services, PAREXEL Consulting