2013 CGMP Conference2013 CGMP Conference2013 CGMP Conference

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An industry hot-topic – this conference is focused on the importance of driving a culture of quality.

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
  • Monica Caphart, Supervisory Consumer Safety, DHHS/FDA/ORA
  • 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
  • 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

View Detailed Information

Industry Leading Events

  • Breakfast with the Regulators 
  • ISPE Exclusive! Drug Shortage Panel 
  • Industry-Lead Hot Topic Discussion
  • Meet the Press

View Detailed Information

 Add the conference to your calendar

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Schedule

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Training Courses

Register for additional training courses being offered. View Training Courses

Justification Toolkit

Find the items you need to justify why you need to attend ISPE CGMP Conference. View the Toolkit
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Handouts

Handouts will be available the week before the conference.

Announcements

Know Before You Go

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

  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Host Sponsor
  • Gold Sponsor

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