Main Conference Sessions Agenda: Day 3

FRIDAY, MARCH 19, 2020

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the country as we begin the final day of PharmaLink with a complimentary warm breakfast.


8:30 AM - 8:50 AM

We do not learn from experience…we learn from reflecting on experience.
— John Dewey

To Your Success! 

Advance your organization by preparing key action plans from the conference that will make a difference for you, your organization and the patients you serve.

Speaker:

  • Marla Phillips, Director, Xavier Health, Xavier University


8:50 AM - 10:05 AM

Global Investigator Insights: Top 10 Investigational Findings

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Regulators will share the top inspectional observations from calendar year 2019, the significance of these findings, and insight on how you can prevent their occurrence at your facility. Additionally, you will gain an understanding of progress and insight from the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Protect your patients with actionable information you can implement today!

Moderator: 

  • Steve Eastham, Supervisor, Consumer Safety Officer, FDA (invited)

Speakers:

  • Anne Hayes, Manager of Inspections, HPRA, on behalf of PIC/S (invited)

  • Jeff Meng, Director of Investigations Branch, Division of Pharmaceutical Quality Operations III, ORA, FDA (invited)

  • Dell Moller, Supervisory Investigator, FDA (invited)

  • ANVISA (confirmed) - Speaker TBD


10:05 AM - 10:25 AM

Break


10:25 AM - 10:55 AM

A View from China

Learn from the FDA China Post what challenges, opportunities, similarities and differences have been observed since the establishment of the FDA China Post. Learn the role the FDA representatives have played, and progress that has been accomplished.

Moderator: 

  • Lindsey Schwierjohann, Drug Specialist, Pharma Division III, FDA (invited)

Speaker: 

  • Leigh Verbois, Assistant Commissioner for International Programs (Acting), FDA (invited)


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10:55 AM - 12:25 PM

Mock Inspection

Love the interaction, and I really appreciate the FDA’s perspective on things.
— PharmaLink 2019 Attendee

Engage in an interactive FDA mock inspection with FDA investigators, with participants from other regulatory agencies sharing their expectations! By exploring challenging scenarios and learning how to address “gray areas” that may arise during your next inspection, you will understand how to prepare your organization for success. Participants will be exposed to 21st Century Inspectional Techniques and how to manage them during the stress of an ongoing FDA inspection. FDA investigators focus on different areas based upon their individual expertise. Learn how to navigate and respond to questions that may seem daunting, while demonstrating a culture of quality at your firm—and avoid FDA leaving with the wrong impression.

Moderator: 

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

Speakers: 

  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA, FDA (invited)

  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, FDA (invited)

  • Steve Eastham, Supervisor, Consumer Safety Officer, FDA (invited)

  • Anne Hayes, Manager of Inspections, HPRA, on behalf of PIC/S (invited)

  • Lauren Howard, Investigator, FDA (invited)

  • Jeff Meng, Director of Investigations Branch, Division of Pharmaceutical Quality Operations III, ORA, FDA (invited)

  • Dell Moller, Supervisory Investigator, FDA (invited)

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

  • Lindsey Schwierjohann, Drug Specialist, Pharma Division III, FDA (invited)

  • John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health


12:25 PM - 12:30 PM

Conference Close-out

Great conference. Looking forward to coming back!
— PharmaLink 2019 Attendee

Thank you for joining us! We look forward to advancing the industry with you throughout the year as you implement the successful practices you learned at PharmaLink 2020!

Speaker: 

  • Marla Phillips, Director, Xavier Health, Xavier University