2014 ISPE CMO Conference

Education Program

Cover the Most Challenging Components of the Owner-CMO Partnership
Regulators, Owners, Contract Manufacturing and Development Organizations

Collaborate on best practices to assure high quality, consistently safe and effective drugs for our patients.

Speakers

Michael Levy
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Senior Counsel, Compliance, FDA/CDER/OC

Regulatory Expectations and Challenges of Contracted Work
Courtney Billington
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VP, Global Pharmaceutical Supply Chain, Johnson & Johnson
Industry Expectations and Challenges of Contracted Work
Steve Leonard
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Sr. VP of Global Operations, Catalent Pharma Solutions

CMO Expectations and Challenges of Contracted Work

Workshops

Examine CMO-Owner relationships and production issues from end to end of the product lifecycle.

Start-up Phase

  • Multi-customer and multi-regulated facilities
  • Product segregations
  • Regulatory expectations
  • CMO due diligence

Selection Phase

  • Product Approval Inspections
  • GMP Inspections
  • Validations
  • Regulatory expectations

Governance

  • Right level of governance to achieve
  • transparency and accountability
  • Auditing
  • Metrics
  • Risk Management
  • Regulatory expectations

Delivery Phase

  • Ongoing development / manufacturing
  • Product distribution
  • Vulnerabilities in the Supply Chain
  • Control and Visibility in Packaging,
  • Data Integrity, Shipping
  • Customs Issues
  • Regulatory expectations

Announcements:

MAKE SURE YOUR COMPANY'S VOICE IS HEARD!  

Discussions from the workshops will be collated for the development of a white paper to inform the development of guidance on this topic.

Featured KEYNOTE Speakers

Michael Levy, Senior Counsel, Compliance, FDA/CDER/OC

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions

Thank you to our PROGRAM COMMITTEE!

Tim Tyson, Chairman and CEO, Aptuit, Inc. – Chair

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions – Co-Chair

Paula Katz, Branch Chief (A), Regulatory Policy & Collaboration, FDA/OMPQ - Co-Chair

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson - Co Chair

Joachim Del Boca, Apotheker, Vetter Pharma-Fertigung GmbH & Co KG