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Life Sciences Conf. & Exhibition - June 17, 2010Thursday, June 17, 2010 at 8:00 AM (ET)Hoboken, NJ |
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Event Details
ISPE-NJ Life Sciences Conference & Exhibition
at the Stevens Institute on
Thursday, June 17th 2010
The Babbio Center
Stevens Institute of Technology
Castle Point on Hudson
Hoboken, New Jersey 07030
(See below for a map and directions)
Registration begins at 7:00AM
Life Sciences Conference and Vendor Exhibition highlighting FIVE Seminar Tracks, composed of the following topics:
| Chapter Day Schedule | |||||
| Location | Room 111 Babbio Center | Room 202 Babbio Center | Room 104 Babbio Center | Room 203 Babbio Center | Room 204 Babbio Center |
| New Risk-MaPP Guideline | Personal Development/ Process Design | Operations and Maintenance/GAMP C&Q | QbD and PAT | New Technologies in Industry and Academia | |
| Session Time | Track A | Track B | Track C | Track D | Track E |
| 8:00 AM | Session A1 Introduction to Risk-Mapp - Stephanie Wilkins President PharmaconsultUS | Session B1 One Man Consulting Panel Discussion - Stephen Fowler, Steve Ostrove, Leonard Mestrandrea | Session C1 Operations and Maintenance of Ultraviolet Generators - Bill LaVoice, Aquafine | Session D1 Analytical Method Development Guided by QbD Principles and Tools Ruben Lozano, Principal Scientist, Analytical R&D BMS | Session E1 Continuous Processing in Manufacturing, Christopher Desantos, Staff Process Engineer J&J |
| 9:00 AM | Session A2 Toxicological Considerations in Risk-MaPP Bruce Naumann Ph.D. Merck | Session B2 How to get an Article Published Doug McCormick | Session C2 Maintenance of HVAC Equipment Phil Patterson, Genesis Engineers, Inc | Session D2 Application of PAT to Monitor and Control Drug Product Manufacturing, Tim Stevens, PhD, Sr, Research Investigator II, BMS | Session E2 Inkjet Printing of Drug-Eluting Micropatterns, Woo Young Lee, Ph.D. Stevens |
| 10:00 AM | VENDOR BREAK | VENDOR BREAK | VENDOR BREAK | VENDOR BREAK | VENDOR BREAK |
| 10:30 AM | Session A3 Cleaning Considerations in Risk-MaPP Andrew Walsh Stevens Institute | Session B3 Water Systems-Transcending Industries Andrew Collentro | Session C3 Operations and Maintenance of Pumps and Valves - Jeremy Steingraeber, Waukesha Pumps | Session D3 Qaulityby Design in Drug Substance Development - Opportunity or Challenge for Commerciaslization, Sushil Srivasta, Director Process R&D BMS | Session E3 Product Level Anti Counterfeiting Features Robert Kowal Associate Director, Master Black Belt, J&J |
| 11:30 AM | LUNCH ISPE Speakers Auditorium/Outdoor Tables | LUNCH ISPE Speakers Auditorium/Outdoor Tables | LUNCH ISPE Speakers Auditorium/Outdoor Tables | LUNCH ISPE Speakers Auditorium/Outdoor Tables | LUNCH ISPE Speakers Auditorium/Outdoor Tables |
| 1:00 PM | Session A4 Containment Considerations in Risk-MaPP Julian Wilkins PharmaconsutUS | Session B4 CIP Considerations Leonid Schnayder Stevens Institute | Session C4 Overview of ASTM E2500 and integration with GAMP5, Steven Wisniewski, Commisioning Agents, Inc. | Session D4 Tech Transfer Challenges in PAT, Dan Wasser, Director BMS | Session E4 Single Use Biotechnology Facilities Dan Bauer Xcellerex |
| 2:00 PM | VENDOR BREAK | VENDOR BREAK | VENDOR BREAK | VENDOR BREAK | VENDOR BREAK |
| 2:30 PM | Session A5/A6 Potent Compound Facility Design: Chandra Sekhar J&J Retired | Session B5 Operations and Maintenance of Sterilizers Gordon Leichter Belimed Aqaufine | Session C5 GAMP5, ASTM-E2500, and future ISPE Guidance on Risk Based Qualifications relative to defining user requirements, with workshop, Tim Howard, Commissioning Agents, Inc. | Session D5 The Foundation for PAT Implementation in Process Development and Manufacturing John Wasylyk, Principal Scientist BMS | Session E5 Polymeric Self-Assemblies for Controlled Delivery of Bioactive Molecules from Surfaces Svetlana Sukhishvilli, PhD, Stevens |
| 3:30 PM | Session C6 Case Study-utilizing both GAMP5 and ASTM E2500 guidelines to determine the strategy for all requiring activities for a fully compliant GLP facility. Joanne Meloro, Validation, Inc. | ||||
| 5:00 PM | COCKTAIL HOUR WITH | HORS D'OEVRES | |||
| 6:00 PM | KEYNOTE SPEAKER | ||||
| ONGOING ALL | DAY- Vendor Table Tops, |
SPECIAL Keynote Address
by Dr. Joseph Saba, CEO of AXIOS
Axios International is a consulting company founded in 1997 that specializes in strategic advice and technical assistance to improve healthcare delivery services in low- and middle-income countries.

ISPE Members $ 150 each. Non-ISPE Members $ 200 each. Students and Faculty - Free after 3PM - Dinner & Dr Saba Presentation only - $75.00 Many Exhibitor Options - See above Ample Complementary Parking at Stevens Institute is available For more information please contact: manager@ispenj.org or 1-908-458-6478
When & Where
Stevens Institute of Technology
Castle Point on Hudson
The Babbio Center
Hoboken,
NJ 07030
Thursday, June 17, 2010 at 8:00 AM (ET)
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Hosted By
ISPE New Jersey Chapter
Caroline Shelly,
ISPE Administrator