• Introduction and Opening Remarks
  Rodolfo Romañach, Ph.D., UPR, Mayaguez, PR

• PAT and Human Resources
  Rodolfo Romañach, Ph.D., UPR, Mayaguez, PR

• Presenting PAT & QbD to FDA
  Thirunellai Venkateshwaran, Pfizer

• Pfizer Experience with Real Time Release Applications
  Tom Garcia, Pfizer, Inc., Groton, CT

• QbD/PAT: Update and Regulatory Perspective
  Vibhakar Shah, Ph.D., Senior Policy Advisor, Division of Manufacturing and Product Quality, Office of Compliance, CDER, FDA, Silver Spring, MD

• Process Monitoring and Control: Particle Characterization
  Angel Martinez, Pfizer

• NIR & NIR-CI for Evaluation of Gel Strips and Polymeric Drug Delivery Systems
  Rodolfo Romañach, Ph.D., UPR, Mayaguez, PR

• Next Generation HPLC: Novel Process Applications
  Rick Cooley, Dionex, Martinsville, Indiana
  

• Approval of Real Time Release
  Carlos Conde-Reyes, Ph.D., Pfizer, Guayama, PR

• In-Process Particle Characterization-FBRM and PVM: Current State of the Art and Recent PAT Case Studies
  Des O'Grady, Mettler Toledo, Columbia, MD

Additional Presentations to follow...

• Expanding your Process Knowledge: Applying Databases and informational procedures within your processes
  Marc Champagne, Eli Lilly, Indianapolis, IN

• Role of Models in Implementing The QbD Paradign: A Regulatory Perspective
  Sharmista Chatterjee, Ph.D, Office of New Drug Quality Assessment, OPS, CDER, FDA, Silver Spring, MD

• Multivariate Batch Analysis, a Powerful Tool for Bioprocess Materials
  Chris McCready, Umetrics

• Transmission Raman for Tablet Analysis
  David Strachen, Kaiser Optical

• Cell Culture and Bioprocess Analysis by Near Infrared Spectroscopy
  Todd Strother, Thermo Fisher Scientific, Lanham, MD

• Engineering and Control for PAT and QbD (TBA)
  Salvador Garcia Muñoz, Ph.D., Pfizer

• Modeling and Engineering in Continuous Pharmaceutical Manufacturing
  Carlos Velázquez, Ph.D., Department of Chemical Engineering, UPR-Mayagüez

• The potential of Continuous Manufacturing: Continuous Oral Solid Dosage Tablet making.
  Rebecca Vangenechten, Siemens AG

• Increasing Process Understanding: The Role of Feed-Frames in Tablet Compression
  Rafael Mendez, Ph.D., Department of Chemical Engineering, UPR-Mayagüez

Additional Presentations to follow...