October 15, 2010 All-Day Event - Presentations

Morning Session

• Incoming Bombshell: FDA's New Process Validation Guidance (abstract)

  presented by Jeff Boatman (Senior Subject Matter Expert, Medical Devices and Quality Systems at QPharma)

• Process Validation - Incorporating Quality Design and Risk Management: A Case Study (abstract)

  presented by Kelly Davis (Regulatory Affairs at Baxter HealthCare)
  

• A Case Study of Process Development for a Lyophilized Vial (Manufacturing Process: Lab Trials, Up-Scaling, Clinical Manufacturing, and Process Validation)

  presented by Susanne Resatz (Vetter)

Afternoon Session

• A Case Study on Registration and Stability Batches of a Biologic Drug Product

  presented by Steve Ensign (Associate Consultant Engineer at Lilly)

• Current Trends in Process Validation - Panel Discussion

  1. Janet Bowen (Director of Quality Systems/Compliance Services at Commissioning Agents)
  2. John Nadelin (Director, Regulatory & Compliance Services at Safis Solutions)
  3. Wes Hines (Senior Scientist in Technical Services at BioConvergence LLC)
  4. Sorin Haias (Lives International Corp.)