14th Annual FDA Inspections Summit Presentations
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SPEAKER BIOS | AGENDA PDF | AGENDA AT-A-GLANCE |
PRE-CONFERENCE WORKSHOPS – Wednesday, Oct. 23, 2019
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
Clinical Trials Preconference Workshop
1:00 p.m. – 5:00 p.m.
ICH E6(R2): How to be Inspection Ready with Your Sponsor Risk Management Program
- Susan Leister, VP, Quality & Compliance, Technical Resources International
Medical Devices Preconference Workshop
1:00 p.m. – 5:00 p.m.
Process Validation for Medical Devices: Preparing for a QSR Inspection
- Dan O’Leary, President, Ombu Enterprises, LLC
DAY ONE – Thursday, Oct. 24, 2019
9:10 a.m. – 10:00 a.m.
FDA and D.C. Politics: A Look at FDA Achievements and What Lies Ahead
- Marc Scheineson, Partner, Alston & Bird LLP
10:00 a.m. – 10:45 a.m.
Auditing Manufacturers: Linking Data Integrity with Quality Culture
- Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.
Drugs & Biologics Track
11:10 a.m. – 12:00 p.m.
Concept of Operations: How Integration of the FDA Facility Evaluation and Inspection Program Impacts Your Organizations
- John Taylor, President/Principal, Compliance and Regulatory Affairs, Greenleaf Health; former Acting Deputy Commissioner for Global
Operations and Policy, FDA
12:00 p.m. – 12:45 p.m.
Audits, Inspections and Management of Suppliers in India and China
- John McKay, CEO and Chief Compliance Officer, Q1 Associates LLC
1:45 p.m. – 3:15 p.m.
Panel Discussion: The US/EU Mutual Recognition Agreement (MRA) for Drug GMP Inspections
Moderator:
- Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health; former Director, Office of Compliance, CDER, FDA
Panelists:
- CPT Helen Saccone, Senior Advisor, Office of Strategic Programs, CDER, FDA
- Chris Markus, Partner, King & Spalding
Clinical Trials Track
11:10 a.m. – 12:00 p.m.
Meeting CRO-Vendor Oversight Requirements
- Liz Wool, President, Wool Consulting Group, Inc.
12:00 p.m. – 12:45 p.m.
Designing Data Integrity into Your Clinical Trials and Responding When an Issue Arises
- Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health; former Director, Office of Compliance, CDER
1:45 p.m. – 2:45 p.m.
Quality by Design – Build Quality into Clinical Trials to Proactively Identify and Mitigate Risks
- Sharon Reinhard, M.S., Executive Director, Merck Research Labs Quality Assurance, Merck & Co., Inc.
Medical Devices Track
11:05 a.m. – 11:55 a.m.
Preparing for a MDSAP Audit: A Case Study from the Manufacturer’s Perspective
- Connie Hoy, Consultant, Hoy & Associates Regulatory Consulting
11:55 a.m. – 12:55 p.m.
Panel Discussion: EU-MDR: Final Push for Compliance by the May 26, 2020 Deadline
Moderator:
- Brian Ludovico, Executive Director, NSF Medical Device Regulatory Certification
Panelists:
- Karl Vahey, Vice President Manufacturing Quality, Cardinal Health
- Dan O’Leary, President, Ombu Enterprises, LLC
- Ibim Tariah, Vice President, EU MDR and IVDR Consulting Services, Regulatory & Quality Solutions (R&Q)
1:45 p.m. – 2:45 p.m.
FDA’s Shift from QSR to ISO 13485:2016: A Significant Change for Inspections
- Kristen Grumet, Senior Vice President, Regulatory Compliance, Greenleaf Health; former FDA Field Investigator specializing in medical devices
PLENARY SESSION
3:00 p.m. – 4:30 p.m.
Panel Discussion: The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site
- Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
- Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.
- John McKay, CEO and Chief Compliance Officer, Q1 Associates LLC
- David Elder, Executive Vice President, Greenleaf Health; former Director, Director, Office of Regional Operations, FDA
4:30 p.m. – 5:30 p.m.
Mock Inspection: Practice Makes Perfect
- Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
- David Elder, Executive Vice President, Greenleaf Health; former Director, Director, Office of Regional Operations, FDA
- Steven Lynn, Principal GxP Consultant/Owner, Lynn Consulting; former Director, Office of Manufacturing and Product Quality, CDER, FDA
- Kristen Grumet, Senior Vice President, Regulatory Compliance, Greenleaf Health; former FDA Field Investigator specializing in medical devices
DAY TWO – Friday, Oct. 25, 2019
9:10 a.m. – 10:00 a.m.
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections
- John Avellanet, Managing Director and Principal, Cerulean Associates LLC
10:00 a.m. – 10:45 a.m.
FDA 483 and Warning Letter Trends
- Chalana Damron, Counsel, Crowell & Moring
11:00 a.m. – 12:00 p.m.
FDA’s Vision and Strategy for Field Programs (No Slides for This Session)
Moderator:
- Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
Panelist:
- Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, FDA