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2016 PDA Annual Meeting
David Allen, PhD
C3: From Development to Commercialization - Technical Transfer Strategies and the Use of Development Data in Validation Plans
(?)
Daniel Blackwood
Presentation not authorized for distribution.
(?)
Jeffrey Blue
(UPDATED) P5: Ensuring Supply of Medicines and Expanding Access
(?)
Scott Bozzone, PhD
(UPDATED) C3: From Development to Commercialization - Technical Transfer Strategies and the Use of Development Data in Validation Plans
(?)
Ciaran Brady, PhD
Breakfast VII: Defining the Product Specification
(?)
Peter Carbone
P3: Improving Efficiency and Reducing Manufacturing Costs
(?)
Dave deBronkart
Presentation currently unavailable.
(?)
Claudio Denoya, PhD
(NEW) IG3: Microbiology/Environmental Monitoring
(?)
Sven Deutschmann, PhD
(UPDATED) A3: Advances in Analytical Technologies for Microbial Controls
(?)
Haodi Dong
(NEW) B3: Review of Single-Use Processing Equipment Experiences and Needs
(?)
Earl Dye, PhD
P4: Rapid Product Development
(?)
Nathalie Frau, PhD
(UPDATED) B1: Ensuring Supply by Using Multiproduct Facilities and Reducing Supply Chain Risk
(?)
Ghada Haddad
(UPDATED) Breakfast II: QRM in Engineering Design
(?)
Marc Hogreve
(UPDATED) B3: Review of Single-Use Processing Equipment Experiences and Needs
(?)
Jeffrey Johnson
(NEW) A2: Challenges and Advances within Downstream Technologies
(?)
Walter Kalmans
(NEW) Breakfast VIII: Post-Approval Life-Cycle Management Plans/Change Management
(?)
Marina Kozak, PhD
(UPDATED) P1: Opening Plenary Session: Putting the Patient First
(?)
Howard Levine, PhD
(NEW) A2: Challenges and Advances within Downstream Technologies
(?)
Louis Masi
(UPDATED) A1: Achieving High Quality and Productivity in Cell Culture Processes
(?)
Dorota Matecka, PhD
(NEW) P4: Rapid Product Development
(?)
Paul Motchnik, PhD
(NEW) C2: Driving Continuous Process Improvement Through Effective Lifecycle Management
(?)
Morten Munk
(NEW) Breakfast I: The Flexible and Agile Facility of the Future
(?)
Tolga Musa
P2: Manufacturing and Supply Considerations to Enable Novel Therapies
(?)
Michele Myers, PhD
P2: Manufacturing and Supply Considerations to Enable Novel Therapies
(?)
George O'Sullivan
(NEW) B1: Ensuring Supply by Using Multiproduct Facilities and Reducing Supply Chain Risk
(?)
Tsutomu Ota
(UPDATED) B2: Adapting Manufacturing Facilities - Case Studies
(?)
Mahesh Ramanadham, PharmD
(NEW) Breakfast VIII: Post-Approval Life-Cycle Management Plans/Change Management
(?)
Johannes Reich
(UPDATED) A3: Advances in Analytical Technologies for Microbial Control
(?)
Susanne Richter, PhD
(UPDATED) Breakfast III: QbD-Enabled Control Strategies/Process Validation of Biosimilar Processes
(?)
Anil Sawant, PhD
(NEW) Breakfast V: Data Integrity
(?)
Susan Schniepp
(NEW) Breakfast V: Data Integrity
(?)
John Shabushnig, PhD
(NEW) IG9: Visual Inspection of Parenterals
(?)
Matt Shields
P3: Improving Efficiency and Reducing Manufacturing Costs
(?)
Jayanth Sridhar, PhD
P5: Ensuring Supply of Medicines and Expanding Access
(?)
Peggy Staver
Presentation not authorized for distribution.
(?)
Ranjit Thakur
(UPDATED) C1: Integrating New Technologies and Products: Processes and Tools for Managing Decisions and Execution
(?)
Sandra True, PhD
IG10: Prefilled Syringes
(?)
Brian Urban
P2: Manufacturing and Supply Considerations to Enable Novel Therapies
(?)
Anders Vinther, PhD
(NEW) Breakfast VIII: Post-Approval Life-Cycle Management Plans/Change Management
(?)
Kelly Waldron
(NEW) IG7: Quality Risk Management
(?)
Karen Walker
A1: Achieving High Quality and Productivity in Cell Culture Processes
(?)
Tongtong Wang, PhD
A1: Achieving High Quality and Productivity in Cell Culture Processes
(?)
Greg Whitehead
C1: Integrating New Technologies and Products: Processes and Tools for Managing Decisions and Execution
(?)
George Wiker
(UPDATED) B2: Adapting Manufacturing Facilities - Case Studies
(?)
Glenn Wright
Breakfast VI: Manufacturing Initiative
(?)
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