Agenda: Day 3
Friday, March 16, 2018
7:45 AM - 8:30 AM
Join your colleagues from around the country as we begin the final day of PharmaLink with a complimentary warm breakfast.
8:30 AM - 8:35 AM
Day 3 Opening
Participants will feel the Xavier Difference at PharmaLink, a purpose driven, action-oriented conference. We will start the day recapping the take-away points from Day 2 through the Act-Change-Transfer process that will lead to the development of action plans for your key learnings. We insist that our content is meaningful and impactful, so you can’t help but walk away with practical applications to implement when you return to work!
- Jennifer L. Brown, Director, Global Chemistry, Manufacturing & Controls, Pfizer
8:35 AM - 9:25 AM
Total Quality Ownership Enterprise-wide: The Missing Piece of the Puzzle
It is imperative that cross-functional partners “own” quality along with the quality organization. This ownership will advance the maturity of the organization operationally and culturally, and must permeate every level of management. We have intentionally included a speaker with experience predominantly grounded in the medical device industry, since that industry has mandatory Quality Management Review requirements through FDA regulation. Don't miss this opportunity to learn successful practices on how to effectively lead a Total Quality organization across 200 companies through practices that are reviewed by FDA on inspection. These practices include:
- Driving operational excellence through effective decisions supported by meaningful metrics and data.
- Establishing seamless processes for enterprise-wide feedback loops to improve lifecycle management and ownership – shifting to a right-first-time mentality as early in the process as possible.
- Engaging employees in external intelligence gathering.
- Fostering cross-functional quality ownership and a culture of curiosity.
- Bill Webb, Senior Director, Quality, US WorldMeds
- Adrienne Brott, Vice President, Quality Systems & Post Market Quality, Global Surgery, Johnson & Johnson
9:25 AM - 9:45 AM
9:45 AM - 10:35 AM
How Do Global Regulators Decide Who to Inspect?
Global regulators all face the same challenge – there are orders of magnitude more firms to inspect than there are regulators. FDA, TGA and MHRA are invited to share with you how they determine which firms to inspect, what strategies they have in place for managing the firms that don’t get inspected, and what actions they are implementing to improve their coverage. Learn where FDA is with its Quality Metrics Submissions work. And perhaps, most importantly, where are global regulators with the adoption of Mutual Reliance, and what are the next steps?
- Tami Frederick, Global Director, Corporate Quality Systems and Programs
- Commander Tara Gooen Bizjak, Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality, FDA (invited)
- Tracy Moore, Senior GMDP Inspector and GMDP Operations Manager, MHRA
10:35 AM - 12:10 PM
FDA Investigator Case Study Insights
FDA will share top trends in industry failures as they explore case studies on what went wrong and why. You will engage with FDA, Industry Experts and your colleagues to explore what could have been done differently that will allow you to walk away with actionable solutions.
- Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding
- Brent Conatser, Senior Consultant, Elanco Animal Health
- Robert Tollefsen, National Expert Investigator, FDA
- Dell Moller, Supervisory Investigator, FDA (invited)
- Nicholas L. Paulin, Drug Specialist and Pre-Approval Manager, FDA, Cincinnati District Office (invited)
12:10 AM - 12:30 PM
To Your Success!
Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve. Work with your colleagues on turning your learning into a practical action plan.
- Marla Phillips, Director, Xavier Health, Xavier University