Highlighted Key Sessions for PDA SciTech Summit

Process Analytical Technologies
Ali Afnan, Ph.D., FDA, CDER, Office of Pharmaceutical Science

Future New Technologies that Will Impact the Industry
Darren Dasburg, Conventure

Update of Harmonization Activities in ICH
Joyce Ramsbotham, Solvay

Introduction Risk Management and Quality Concepts
Michael Van der Werf, Aventis Behring

Closed Vial Line: A New Concept in the Aseptic Filling of Sterile Injectables
Jacques Thilly Aseptic Technologies,
GlaxoSmithKline Biologicals, Belgium

Defining and Meeting Expectations in Multi- Product Biopharmaceuticals
Heidi Reichert, Wyeth Biopharma
Christopher Bussineau, Director, Manufacturing, Chiron Corporation

Expectations and Assurance in Maintaining Validated Biopharmaceutical Operations
John Finkbohner, FDA, CBER
Christopher Joneckis, Ph.D., FDA,, CBER
Laurie Norwood , FDA, CBER

WHO Supplementary Guideline on GMPs: Validation
Stephen Bellis, AstraZeneca

Counterfeit Pharmaceuticals:
Symptoms, Diagnosis and Developing Treatment
Lewis T. Kontnik, Principal, Lew Kontnik Associates
Mike Anisfeld, GlobePharm Consulting

Annual Product Reviews: Technical, Business Process, Key Outcomes and Considerations
Carmel Egan, PhD, Eli Lilly and Company

Validation and Quality by Design
Gerry Migliaccio, Pfizer, Inc.

New Methods of Sterilization: Radiation Sterilization
Alp Yaman, Ph.D., Director, Pharmaceutical Technology Transfer, Worldwide Technical Services, Schering-Plough, Inc.

Current Trends in Automated In-Situ Steam Sterilization for Bioreactors and Related BioProcessing Equipment
Ernest Stadler, BIOSCIPRO

Rapid Microbial Methods
Michael Miller, Ph.D., Eli Lilly and Company

Understanding Process Analytical Technologies
Bruce Bird, Pfizer

Emerging Issue: Virtual Drug Development
Managing the Supply Chain
Quality Assurance at the Vendor and Sponsor
Dave Moyer, Fulcrum Pharma, Inc.


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