New education tracks at the ISPE/FDA/PQRI Quality Manufacturing Conference have been designed to bring you practical information to help your company succeed.

New Topics!

Transformation of Quality Oversight

  • Q11 Development and Manufacturing of Drug Substance
  • Quality Risk Modeling and Management
  • Excipient Risk-Assessment Guidance
  • OPQ Perspectives on Risk-Based Review
  • Inspection of Combination Products
  • Product Traceability Implementation

Frontiers in Manufacturing Science and Quality

  • FDA New Technology Initiative
  • Latest Developments in 3D Printing, Nanotechnology, High-Potency Drugs, and Injectables
  • FDA/Industry Collaborations in Innovation
  • Impact of Emerging Technologies on Manufacturing Development

Manufacturing and Operational Excellence

  • Manufacturing Issues Impacting Drug Shortages
  • Critical Excipients in the Supply Chain
  • Controlling Supply Chain Variability
  • Driving a Culture of Continuous Improvement
  • ICH Q12 on Currently Marketed Products

Plus, don’t miss these key sessions:

  • Breakfast with the Investigators – Front-line regulators share their insights.
  • Quality Metrics – What’s next? How can my company prepare for implementation?
  • Industry and Regulatory Discussion Forum – Face-to-face dialogue with industry thought-leaders and global regulatory representatives.

Register for Quality Manufacturing Conference



Register by 9 May 2016 and Save!
Discounted Student and Group Rates are Available
Learn about Exhibit and Sponsorship Opportunities

Save the Date! ISPE Data Integrity Workshop: 5 June 2016
Arrive a day early to participate in this highly interactive session!
Registration coming soon