Schedule
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Training Courses
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For a second year, ISPE and FDA have collaborated to create a joint conference focused on the future vision of the pharmaceutical industry and the importance of driving a culture of quality throughout companies and regulatory agencies.
The event will assemble the entire supply chain to discuss industry’s commitment to identifying and adopting quality practices that continue to deliver a safe, consistent and available global drug supply.
Expert speakers and solution-focused sessions will discuss quality and manufacturing challenges, as well as provide attendees with new insights and executable action plans.
Gain an understanding of how to build and sustain a quality culture so your organization
can:
• Improve Process • Minimize Risk • Decrease Cost • Increase Flexibility • Remain Compliant
Regulatory Participation
- Ilisa Bernstein, Deputy Director, Office of Compliance, CDER, FDA
- Ernie Bizjak, Compliance Officer, OHHS/FDA/ORA/OGROP
- Paula Katz, Sr. Policy Advisor, OMPQ/FDA
- Dave Doleski, Director, DGMPA, FDA
- Rick Friedman, Associate Director, OMPQ, FDA
- Ray Gaines, Chemist, CDER, FDA
- Krishna Ghosh, Compliance Officer CDER/Office of Compliance, FDA
- Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA, UK
- Brooke Higgins, Pre-Approval Manager/Investigator, OHHS/FDA/ORA/OGROP
- Karthik Iyer, Senior Policy Analyst, FDA
- Valerie Jensen, Associate Director for Drug Shortage, CDER, FDA
- Steve Lynn, Senior Advisor to the Assistant Commissioner for Operations/Office of Regulatory Affairs/Office of Operations Immediate Office, FDA
- Carmelo Rosa, Director, DIDQ, FDA
- Francis Godwin, Branch Chief, GDMAB FDA
- Russ Wesdyk, Science Coordinator, FDA/CDER/OPS/OI
- Alex Viehmann, Operations Research Analyst, FDA
- Howard Sklamberg, Director, Office of Compliance, FDA
- Mike Smedley, Acting Director, OMPQ, FDA
Session Topics
- Quality Metrics
- Quality Leadership
- Process Performance and Product Quality Monitoring System
- CMOs
- PAI Readiness
- CAPA
- Facility Investment
- Cloud Technology
Industry Leading Events
- Breakfast with the Inspectors
- ISPE Exclusive! Drug Shortage Panel
- Industry-Lead Hot Topic Discussion
- Meet the Press
Announcements
Quality Metrics Session - Participate in discussions aimed at advancing industry-wide change. Gain insight into FDA's planned direction, challenges to alignment across industry and a recommended path forward.
Val Jensen, Associate Director for Drug Shortage, CDER, FDA confirmed to present Consequences of Drug Shortages
ISPE confirms 15 participating regulators
Be among the first to hear results of ISPE’s Drug Shortage Survey!
Plenary Speakers: Howard Sklamberg, J.D., Andy Skibo, Gerald Heddell, John Pinion and Jaspreet Gill
New! Breakfast with the Regulators
The Chesapeake Bay Area Chapter presents their 2013 Summer Social: Orioles Game on 13 June!
Thank you to our Top Tier Sponsors
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