Gain a better understanding of US FDA and international regulatory requirements during panel discussions
and understand how to optimize lifecycle costs through interactive workshops. Plenty of networking
opportunities will be available.
Plenary Speakers
Sustainable Value Creation Through Efficient Utilities
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James A.
Breen
Vice President Worldwide Engineering and Technical Operations, Johnson & Johnson, USA
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Jed
Richardson
Global Energy Director, Johnson & Johnson, USA |
Regulatory Speakers
General Conference Session: Regulatory Perspectives on Critical Utilities
Tara R. Gooen, Acting Branch Chief, FDA/CDER/OMPQ, Invited
Derek Smith, Interdisciplinary Scientist, FDA/CDER/OMPQ, Invited
General Conference Session: Regulatory and Industry Panel with Q&A
Moderator: Rose Mary Dollard, Director, Compliance Remediation, Johnson & Johnson, USA
Panel Participants:
Tara Gooen, Acting Branch Chief, FDA/CDER/DMPQ USA, Invited
Derek Smith, Interdisciplinary Scientist, FDA/CDER/DMPQ, Invited
Jim Breen, Vice President Worldwide and Technical Operations, Johnson &
Johnson USA
Jed Richardson, Global Energy Director, Johnson & Johnson USA
and Track Leaders
Education Tracks
Track 1: Pharmaceutical Water Systems and Ozone
Leaders
At the conclusion of the session, participants will be able to:
- Reduce energy consumption throughout the lifecycle, from system design and control strategies, through
installation, testing, turnover and maintenance
- Cut utility costs dramatically through cost-efficient distribution and control system designs, recycling
of water and sanitization of water systems
- Optimize microbiological contamination control through timely and cost-effective use of VFD controls,
filtration with less water waste, and quality sampling
Speakers
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Nissan Cohen, Business Development Manager, Rohrback Cosasco Systems, Inc., USA
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Andre Gill, Engineer, Alexion Pharmaceuticals, Inc, USA
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Nicholas Haycocks, Senior QA Specialist, Amgen, USA
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Paolo Michele Leani, Technical Director, Stilmas SpA, Italy
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Joseph Manfredi, President, GMP Systems Inc, USA
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Peter Noverini, USA
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Brian Pochini, CPIP, Principal Engineer, Genzyme Corp, A Sanofi Company, USA
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Brian Severson, Project Manager, Kroeschell Engineering Company, USA
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Cristina Testoni, US Commercial Manager, Stilmas USA, USA
Track 2: HVAC and Process Gases: Strategies for Minimizing Cost
Leaders
- Peter Gardner, Sustainability Manager, Torcon Inc, USA
- Derek Mullins, Senior Manager-Corporate Facilities & Engineering, Amgen, Ireland
At the conclusion of the session, participants will be able to:
- Apply case study examples to optimize lifecycle costs
- Reduce the cost and ensure the sustainability of new and retrofitted facilities
- Insure project approval through effective cost analysis and ROI standard models and a focus on energy
savings vs. capital savings
Speakers
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Mark Butler, Sr. Vice President/Principal, IPS, USA
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Vincent Cebular, VP Compliance Services, IPS, USA
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Mario Don Porto Carero, Senior Principal Engineer HVAC, Johnson & Johnson, Belgium
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Norman Goldschmidt, Principal, Genesis Engineers Inc, USA
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Dan Milholland, Partner, Milholland & Associates, USA
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Gordon Sharp, Chairman, Aircuity, Inc., USA
Pharma Cafe
Cutting-Edge Technologies in Critical Utilities
Leaders
The session will be focused on rapid micro, continuous particle monitoring, gas quality testing and
on-line rouge monitoring technologies for Critical Utilities. Suppliers are invited to participate in Round
Table discussions with industry members to showcase these technologies.
Speakers
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Nissan Cohen, Business Development Manager, Rohrback Cosasco Systems, Inc., USA
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Jianping Jiang, Chief Technical Officer, Instant BioScan,
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Dan Milholland, Partner, Milholland & Associates, USA
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Peter Noverini, Field Applications Scientist, BioVigilant, USA
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Ruby Ochoa, Owner, Trace Analytics LLC, USA
General Conference Session: Shareholder Benefits of a Comprehensive Water Program
Speaker
Phillip Sumner, PE,
Senior Manager, Pfizer, Inc. USA
Thank you to our Top Tier Sponsors
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