Click the session title to view the presentation.

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