Main Conference Sessions Agenda: Day 3

FRIDAY, MARCH 15, 2019


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 - 8:50 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.


  • Marla Phillips, Director, Xavier Health, Xavier University

8:50 AM - 10:05 AM

FDA Quality Metrics Program: FDA Gemba Journey with Industry through Feedback and Site Visit Options


The goal of the CDER metrics program has been to identify differences in risk from company-to-company. In an effort to advance the progress its metrics program, CDER has announced the FDA Quality Metrics Feedback Program, and the Site Visit Program—giving industry an opportunity to demonstrate how it captures, manages, and acts upon its own metrics. This session will link the history of the FDA Metrics Program to the Feedback Program and Site Visit Program, giving industry a voice in the development of this important Pharmaceutical Quality for the 21st Century Program. Participants will walk away with a clear understanding of the intent and direction of FDA’s Quality Metrics Programs, and can utilize this knowledge to determine if they would like to voluntarily participate in sharing their practices with FDA either through a site visit or a formal feedback meeting. 


  • Tami Frederick, Global Director, Corporate Quality Systems and Programs, Perrigo


  • Jennifer Maguire, Division Director (Acting), OPQ/OS/Division of Quality Intelligence, Risk Analysis and Modelling, FDA-CDER

10:05 AM - 10:25 AM


10:25 AM - 11:25 AM

Real Life Application of ICH Q12 in Action

One of the newest ICH guidelines, ICH Q12, focuses on pharmaceutical lifecycle management. What better way to more fully understand the power of this guidance than to hear directly from functional areas that span the lifecycle of your product?  Learn successful practices that can be implemented from the beginning of product development for your new products, or retrospectively for your legacy products.  Don’t miss this opportunity to learn how best to manage your product!  


  • Michael Kaminski, Principal Scientist, Oral Care Regulatory Affairs, P&G


  • Megan McMahon, Director, Global Regulatory CMC, Pfizer

  • Mahesh Ramanadham, OPF Senior Scientific and Policy Advisor (Acting), FDA-CDER


11:25 AM - 12:25 PM

Top 10 FDA 483 Inspectional Observations: How and Why

FDA will share the top ten Inspectional Observations from calendar year 2018. FDA staff will discuss the significance of these findings, and offer steps you can take to prevent their occurrence at your facility. Protect your patients with actionable information you can implement today!


  • Nicholas L. Paulin, Drug Specialist and Pre-Approval Manager, FDA, Cincinnati District Office (invited)


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

  • Dell Moller, Supervisory Investigator, FDA

12:25 PM - 12:30 PM

Conference Close-out

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 2019!


  • Marla Phillips, Director, Xavier Health, Xavier University