Implementing Next Steps for Pharma Quality Metrics
The 2017 ISPE/FDA/PQRI Quality Manufacturing Conference offers a new and exciting format where participants will be able to interact directly with pharmaceutical industry and regulatory leaders in a four-series workshop rotation. Today’s blog focuses on the details of Implementing Next Steps for Quality Metrics, one of the four core workshops taking place at the conference.
The FDA Draft guidance on Quality Metrics was reissued considering industries comments on the first draft. Now what? ISPE has been leading the charge to bring pharmaceutical industry and regulators together to create an open dialogue about shaping the Quality Metrics program as it is launched industry wide. Industry has given input that the current program is heavy on burden and light on benefit. This is your opportunity to explore and engage in dialog with your peers and FDA on the path forward … to drive greater value out of a quality metrics program for patients, industry and FDA.
Objective of the Workshop:
- Create a vision for a quality metrics program that drives continual improvement and more effective and efficient regulatory oversight
- Expand and change perspectives on the overall intent and goals of quality metrics for both FDA and industry
- Consider which metrics are the most powerful in predicting and measuring the performance and health of quality systems
- Betsy Fritschel, Director, Quality & Compliance, Johnson & Johnson
- Steven Greer, Corporate Quality Assurance, External Engagement Leader, Procter & Gamble
- Jennifer Maguire, PhD, Division Director (Acting), Office of Surveillance, FDA/CDER/OPQ
- Sarah Pope Miksinski, PhD, Director, Office of New Drug Products; Director (Acting), Office of Surveillance, FDA/CDER/OPQ
- Bryan Winship, Senior Director Global Quality Risk Management, Mylan
Tired of listening to talk after talk? Learn why the 2017 IPSE/FDA/PQRI Quality Manufacturing Conference will be unlike any pharmaceutical industry conference you’ve experienced before!
2017 ISPE/FDA/PQRI Quality Manufacturing Conference
The 5th Annual ISPE/FDA/PQRI Quality Manufacturing Conference offers you the unique opportunity to interact directly with industry and regulatory leaders to identify real solutions to your organization’s challenges on key issues. Sessions are designed to encourage open discussion about current FDA priorities and industry-critical quality initiatives.