Pharmaceutical Technology Magazine, the leader in cutting-edge information for the pharmaceutical industry, presents a case study-driven conference and exhibition.  This dynamic event will bring together global industry leaders and regulatory representatives who will present their experiences and showcase their products in three tracks: 

  • Global Quality Initiatives
  • FDA Inspections
  • Lean Design and Deployment 

Participants will attend interactive workshops and receive actionable tools to implement immediately from R&D through Manufacturing!

  

Global Quality Initiatives:
Risk Management, Quality Systems, QbD - FDA Update and Case Studies, ICH Q8, Q9 and Q10, Training Programs, NewChapters in USP, Change Management, IT Infrastructure and More!

Track Advisor: Dr. J. Hwa Guo, Ph.D., Wyeth Consumer Healthcare

 
FDA Inspections:
Pre-Approval Inspections, Complaint Handling, CAPA Systems, Communicating with Investigators, Internal Audits, Pfizer QbD Submission Case Study, System-Based Inspections, Vendor Audits and More!

Track Advisor: Rebecca Fuller, President, BioAssist


Lean Design and Deployment:

Reducing Variation, Lean Labs, 10-50% Improvements in Months, Lean in R&D, Lean Manufacturing Deployment, Simulation Modeling, Visible Planning, Six Sigma and More!

Track Advisor: Brian K. Nunnally, Ph.D., Associate Director in To&PS Regulatory Affairs, Wyeth;
John McConnell, Principal, Wysowl Pty Limited, Australia