2016 PDA Annual Meeting

Parenteral Drug Association Connecting People, Science and Regulation ^®

2016 PDA Annual Meeting

David Allen, PhD

C3: From Development to Commercialization - Technical Transfer Strategies and the Use of Development Data in Validation Plans

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Daniel Blackwood

Presentation not authorized for distribution.

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Jeffrey Blue

(UPDATED) P5: Ensuring Supply of Medicines and Expanding Access

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Scott Bozzone, PhD

(UPDATED) C3: From Development to Commercialization - Technical Transfer Strategies and the Use of Development Data in Validation Plans

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Ciaran Brady, PhD

Breakfast VII: Defining the Product Specification

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Peter Carbone

P3: Improving Efficiency and Reducing Manufacturing Costs

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Dave deBronkart

Presentation currently unavailable.

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Claudio Denoya, PhD

(NEW) IG3: Microbiology/Environmental Monitoring

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Sven Deutschmann, PhD

(UPDATED) A3: Advances in Analytical Technologies for Microbial Controls

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Haodi Dong

(NEW) B3: Review of Single-Use Processing Equipment Experiences and Needs

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Earl Dye, PhD

P4: Rapid Product Development

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Nathalie Frau, PhD

(UPDATED) B1: Ensuring Supply by Using Multiproduct Facilities and Reducing Supply Chain Risk

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Ghada Haddad

(UPDATED) Breakfast II: QRM in Engineering Design

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Marc Hogreve

(UPDATED) B3: Review of Single-Use Processing Equipment Experiences and Needs

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Jeffrey Johnson

(NEW) A2: Challenges and Advances within Downstream Technologies

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Walter Kalmans

(NEW) Breakfast VIII: Post-Approval Life-Cycle Management Plans/Change Management

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Marina Kozak, PhD

(UPDATED) P1: Opening Plenary Session: Putting the Patient First

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Howard Levine, PhD

(NEW) A2: Challenges and Advances within Downstream Technologies

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Louis Masi

(UPDATED) A1: Achieving High Quality and Productivity in Cell Culture Processes

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Dorota Matecka, PhD

(NEW) P4: Rapid Product Development

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Paul Motchnik, PhD

(NEW) C2: Driving Continuous Process Improvement Through Effective Lifecycle Management

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Morten Munk

(NEW) Breakfast I: The Flexible and Agile Facility of the Future

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Tolga Musa

P2: Manufacturing and Supply Considerations to Enable Novel Therapies

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Michele Myers, PhD

P2: Manufacturing and Supply Considerations to Enable Novel Therapies

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George O'Sullivan

(NEW) B1: Ensuring Supply by Using Multiproduct Facilities and Reducing Supply Chain Risk

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Tsutomu Ota

(UPDATED) B2: Adapting Manufacturing Facilities - Case Studies

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Mahesh Ramanadham, PharmD

(NEW) Breakfast VIII: Post-Approval Life-Cycle Management Plans/Change Management

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Johannes Reich

(UPDATED) A3: Advances in Analytical Technologies for Microbial Control

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Susanne Richter, PhD

(UPDATED) Breakfast III: QbD-Enabled Control Strategies/Process Validation of Biosimilar Processes

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Anil Sawant, PhD

(NEW) Breakfast V: Data Integrity

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Susan Schniepp

(NEW) Breakfast V: Data Integrity

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John Shabushnig, PhD

(NEW) IG9: Visual Inspection of Parenterals

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Matt Shields

P3: Improving Efficiency and Reducing Manufacturing Costs

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Jayanth Sridhar, PhD

P5: Ensuring Supply of Medicines and Expanding Access

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Peggy Staver

Presentation not authorized for distribution.

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Ranjit Thakur

(UPDATED) C1: Integrating New Technologies and Products: Processes and Tools for Managing Decisions and Execution

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Sandra True, PhD

IG10: Prefilled Syringes

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Brian Urban

P2: Manufacturing and Supply Considerations to Enable Novel Therapies

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Anders Vinther, PhD

(NEW) Breakfast VIII: Post-Approval Life-Cycle Management Plans/Change Management

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Kelly Waldron

(NEW) IG7: Quality Risk Management

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Karen Walker

A1: Achieving High Quality and Productivity in Cell Culture Processes

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Tongtong Wang, PhD

A1: Achieving High Quality and Productivity in Cell Culture Processes

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Greg Whitehead

C1: Integrating New Technologies and Products: Processes and Tools for Managing Decisions and Execution

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George Wiker

(UPDATED) B2: Adapting Manufacturing Facilities - Case Studies

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Glenn Wright

Breakfast VI: Manufacturing Initiative

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