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Optimize Analytical Method Development Strategies

June 26 - 28, 2007 | The Ritz-Carlton Philadelphia, Philadelphia, PA

Main Conference Day One

Main Conference Day One

Wednesday, June 27th, 2007

8:00Registration & Morning Coffee
8:45

Chairperson's Welcoming Remarks

Susan J. Schniepp, Manager, Compendial Compliance, HOSPIRA

Fred Rabel, PhD, former Marketing/Technical Manager, EMD CHEMICALS, a division of Merck KGaA and President, CHROMHELP, INC.

9:00

Exploiting Forced Degradation Studies to Develop a Stability-Indicating HPLC Method: The Chicken or the Egg Paradox

Tessi Kanavarioti, PhD, Sr. Scientist, Pharmaceutical Sciences, AFFYMAX, INC.

9:45

Emerging Technologies for Pharmaceutical Impurity Detection and Characterization

Qingxi Wang, PhD, Director, Global Pharmaceutical Commercialization, MERCK & COMPANY

10:3030 Minute Networking and Refreshment Break
11:00

CASE STUDY
Effective and Efficient Method Development using Snyder Dolan's Column Database

Yun Mao, PhD, Research Fellow, MERCK & COMPANY

11:45

CASE STUDY
Optimization of Static Headspace Capillary Gas Chromatography for Rapid Determination of Formaldehyde and Acetaldehyde in Pharmaceutical Excipients

Laura K. Jacobus, Staff Chemist, MERCK & COMPANY

12:30Luncheon
1:45

CASE STUDY
Develop and Validate Analytical Methods for Genotoxic Impurities

Shufang Niu, PhD, Senior Research Investigator II, Schering Plough

2:30

CASE STUDY
Determine, Test and Control Impurities that Possess Potential for Genotoxicity using Staged TTC Approach

Tao Wang, PhD, Director, MERCK & COMPANY

3:1530 Minute Networking and Refreshment Break
3:45

CASE STUDY
Development of a Rapid Method for Simultaneous Determination of Potency and Impurities of Anionic, Cationic, and Neutral Metal Complexes

David Loffredo, PhD, Manager, Global Product Development, HOSPIRA

4:30

PANEL DISCUSSION
Orthogonal Methods-What are the Most Appropriate Testing Tools for Method Development?

Laura K. Jacobus, Staff Chemist, MERCK & COMPANY

Yun Mao, PhD, Research Fellow, MERCK & COMPANY

Partha S. Mukherjee, PhD, Associate Principal Scientist, Pharmaceutical and Analytical R&D, ASTRAZENECA PHARMACEUTICALS LP

Shufang Niu, PhD, Senior Research Investigator II, Schering Plough

5:15

Day One Concludes



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