12th Annual FDA Inspections Summit Presentations


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PRE-CONFERENCE WORKSHOPS – Wednesday, Nov. 1, 2017

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.
To QSIT or Not To QSIT – That is not the Question!

  • Julie Larsen, Principal/Director, Inspection Readiness Services, BioTeknica
  • Braulio Ortiz , Principal/Project Manager/Senior Quality Engineer, BioTeknica, Inc.

 

DAY ONE – Thursday, Nov. 2, 2017

8:45 a.m. – 9:30 a.m.
FDA’s ORA Reorg and What it Means for Inspections

  • Ellen Morrison, Assistant Commissioner for Medical Products and Tobacco Operations, Office of Regulatory Affairs, FDA

9:30 a.m. – 10:15 a.m.
The World of FDA Quality Metrics: Yesterday, Today and Tomorrow

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

10:15 a.m. – 11:00 a.m.
Postmarket Adverse Event Reporting and cGMP: What You Absolutely Need to Know

  • Katlin Backfield, Attorney at Law, Consultant, Backfield PLLC; former Associate Chief Counsel for Drugs, OCC, FDA

 

Drugs & Biologics Track

11:30 a.m. – 12:15 p.m.
The New Concept of Operations Agreement

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

12:15 p.m. – 1:00 p.m.
Cautionary Tales: Words to the Wise on Compliance

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

2:00 p.m. – 3:30 p.m.
The US/EU Mutual Recognition of Drug GMP Inspections: Practical Consequences for Manufacturers

Moderator:

  • David Chesney, Principal and General Manager, DL Chesney Consulting, LLC; former FDA District Director for the San Francisco office

Panelists:

  • Niraj Mehta, PhD, Associate Director for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, OC, FDA
  • Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf; former Director of the Office of Compliance, CDER, FDA
  • Katlin Backfield, Attorney at Law, Consultant, Backfield PLLC
  • Peter Leininger, Counsel, King & Spalding; former Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel

 

Medical Devices Track

11:30 a.m. – 12:15 p.m.
CDRH’s New Inspection Strategy for 2018: How it Will Impact Your Company

  • CAPT Sean Boyd, Acting Director, Office of Compliance, CDRH, FDA

12:15 p.m. – 1:00 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

2:00 p.m. – 3:30 p.m.
Panel Discussion: European Medical Device Regulations — Preparing for the Storm

Moderator:

  • Lenita Y. Sims Spears Senior Quality Consultant/Senior Regulatory and Compliance Counsel, BioTeknica

Panelists:

  • Dan O’Leary, President, Ombu Enterprises LLC
  • Ibim Tariah, Technical Director, BSI Americas Inc.
  • Karl Vahey, Vice President Manufacturing Quality, Cardinal Health

 

PLENARY SESSION PANEL DISCUSSION

3:50 p.m. – 5:15 p.m.
Ins and Outs of Complaint Management: Experts Share How to Avoid Warning Letters (No slides for this session)

Moderator:

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

Panelists:

  • Dan O’Leary, President, Ombu Enterprises LLC
  • Vicky Stoakes, President, IntegRx, Inc.; former FDA Chemist, ACNA and Investigator, Atlanta District Office Drug Cadre
  • Julie Larsen, Senior Partner, Director Inspection Readiness Services, BioTeknica

 

DAY TWO – Friday, Nov. 3, 2017

8:45 a.m. – 9:30 a.m.
FDA’s Office of Regulatory Affairs: Enforcement Update

  • Douglas Stearn, Director, Office of Enforcement and Import Operations, ORA

9:30 a.m. – 10:15 a.m.
Building Your Best Internal Audit Team for Quality Results

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

10:30 a.m. – 12:00 p.m.
How to Deal with Difficult Inspections

  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding LLP; former FDA Deputy Associate Commissioner for Regulatory Operations
  • David Chesney, Principal and General Manager, DL Chesney Consulting, LLC; former FDA District Director for the San Francisco office