Drug Product Quality Summit
3rd December 2012 — 4th December 2012

Preventing Contamination and Ensuring Quality in Fill Finish and Primary Packaging Operations for Small Molecules and Biologics

Event Overview

IBC's Drug Product Quality Summit is the only event that focuses on ALL the nightmares... the hot button issues that have resulted in millions of dollars lost in the industry due to 483's, clinical holds, and lots rejected due to quality problems. This is the one event where quality and related professionals can quickly learn about the most recent failures and findings that caused drug shortages, plant closings and expensive loss of product in a convenient two-day forum.

Hear Problem-Solving Case Studies on:

• Risk Management for Raw Materials and Supply Chain
• Fill Finish Manufacturing: Current Challenges and Solutions
• Investigations of Quality Deviations: Lessons Learned
• Glass Quality, Primary Packaging and Devices

Early Confirmed Speakers

Formulation Development and Fill Finish Process of ADC's (antibody-drug conjugates) (working title)
Shan Jiang, Ph.D., Director, Formulation and Fill Finish, Seattle Genetics, Inc.

Excipient Stability and Impact on Drug Product Quality (working title)
J. Andrea Ji, Ph.D., Senior Scientist, Late Stage Process Development, Genentech, Inc.

Quality audit and vendor qualifications (working title)
Melissa Morandi, VP of Quality, Acceleron Pharma

Case Study / Unpublished Data
Risk Assessment for Extractables and Leachables: Chemistry Perspective
Dennis R. Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corporation

Evaluation of Filling Pumps (working title)
Nishant Bhasin, Ph.D., Senior Scientist, Centocor/Johnson & Johnson

Sterility Assessment Tools for Sterile Manufacturing Facilities
William H. Miele, Ph.D., Director / Team Leader, Quality Systems and Technical Services, Microbiology / Aseptic Support, Pfizer Global Supply, Pfizer

Scientific Advisory Committee

Michael Gorman, Ph.D., Director, Quality Operations, Pfizer Inc.

Carl "Charlie" Hitscherich Jr., Ph.D., Associate Director Drug Product Process Development and Manufacturing Support, Pharmaceutical Development, Biogen Idec

Michael G. Mulkerrin, Ph.D., Vice President, Process Development, OncoMed Pharmaceuticals
Melissa Perkins, Ph.D., Senior Director, Drug Product Sciences, BioPharm. Dev. Division, Human Genome Sciences, Inc.

Mark Yang, Ph.D., Director, Fill Finish Development, Genzyme, a Sanofi Company

Expected Number of Attendees

NA

View Conference Website: Drug Product Quality Summit

Price of Attendance

n/a

Brochure

View Event Brochure

Location

Raleigh
Raleigh
Raleigh
United States
Raleigh