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Master Operational Excellence

2016 ISPE/FDA/PQRI Quality Manufacturing Conference

The Manufacturing and Operational Excellence Track at the 2016 ISPE/FDA/PQRI
Quality Manufacturing Conference will help you benchmark your company’s practices against those with demonstrated success at improving manufacturing quality and preventing drug shortages. Learn new strategies and gain crucial knowledge from these informative sessions:

  • Driving a Culture of Continuous Improvement
  • Building and Sustaining a Culture of Continuous Improvement in a Global Pharmaceutical Company
  • Impact of Critical Utilities on Quality
  • Lifecycle Management
  • ICH Q12 on Currently Marketed Products
  • Current FDA Perspectives on Continued Process Verification (PV Stage 3)
  • Panel Discussion on Pharmaceutical Lifecycle Management
  • Advancements in Process Capability (Two-Part Session)
  • Process Capability from an FDA Perspective
  • A Statistical Approach to Process Capability
  • Compliance vs. Performance
  • One OTC and Generic RX Companies: Global Approach
  • Process Capability Maturity Model
  • Panel Discussion with all Speakers
  • Drug Shortages Prevention
  • Understanding the Drug Shortages Prevention Gap Assessment Tool
  • Supply Chain Robustness
  • Case Study: Mitigating Risk for Drug Shortages
  • The Drug Shortages Pew Research Project

For more information, please visit the conference website and check out the blog post, Interact with Regulators & Gain Crucial Knowledge at Quality Manufacturing Conference featuring a video from John Burnas.

Arrive a day early to participate in the ISPE Data Integrity Workshop on 5 June 2016.  Registration coming soon!

2016 ISPE Quality Manufacturing Conference Early Bird Registration

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Master Operational Excellence


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