2012 Technology Show Speakers

Keith Bader, Hyde Engineering + Consulting

  • Process Analytical Technology (PAT) for Enhanced Verification of Bioprocess System Cleaning (Quality Track)
  • Efficiencies & Challenges of Online Instrumentation Technology (Smart Asset Management Track)

John Balchunas, NC Biotech Center

  • Maneuvering Online Applications and Modern Resume Writing (Career Development Track)

Tim Blackburn, Pfizer

  • Quality by Design (QbD): Challenges and Opportunities from an Engineering Perspective (Quality Track)

Mike Cook, Grifols

  • Program of the Year- Grifols Predictive Maintenance (Facilities Track)

Michael Drues, Vascular Sciences

  • Michael Drues: Future Manufacturing and Packaging Issues in Clinical Trials and Combination Products: What has worked in the past may not in the future! (Smart Asset Management Track)

Jim Erickson, Blue Mountain Quality Resources

  • Efficiencies of Paperless Maintenance & Calibration Systems (Smart Asset Management Track)

Steve Errico, Tim Dyer, Anita Garrett,  Eisai

  • Sterile Fill Isolators - Case Study (Facilities Track)

Keith Gibbs, Yonkers Industries, Chair ISPE Project Management COP

  • Pitfalls and Hurdles of the Procurement Process in the Pharmaceutical Industry (ISPE - Community of Practice Track)

Nat Hentz, BTEC

  • Evaluation of Rapid Offline Microbial Contamination Detection of Fermentation Processes (Quality Track)

Paul Hochi, Jacobs

  • Recent Trends in Modularization (Facilities Track)

Kevin Martin, Azzur Group LLC, Chair, ISPE GAMP Americas COP

  • Risk-Based Validation- The Benefits of the GAMP Approach (ISPE- Community of Practice Track)

Rodney Perkins & Michael Parks, PCI & Pfizer

  • Efficiency gains from aligning a Calibration & Maintenance Program with the ASTM E2500 Qualification Approach (Smart Asset Management Track)

James Phillips & Ben Desonglo, Biogen Idec

  • Technology Transfer- Achieving What Others Say Can’t Be Done (Facilities Track)

Carson Price, Grifols

  • Increase Equipment Efficiency via Strong Calibration & Maintenance & Predictive Maintenance Programs (Smart Asset Management Track)

Sergi Roura, Grifols

  • Grifols: Who We Are, What We Do and How We Approach Certain Aspects of Engineering (Facilities Track)

David Smith, Kelly Services

  • Interviewing Tips & Skits (Career Development Track)

Ron Snee, Snee Associates

    • Experimental Strategies for Implementing Quality by Design (QbD) (Quality Track)

TC Soli & Nissan Choen
TC Soli, Soli Pharma Solutions, Inc., Member of ISPE Critical Utilities COP Steering Committee and contributing author to the ISPE Baseline Guide for Water and Steam Systems. Nissan Choen, Rohrback Cosaco Systems, Inc., Member of ISPE Critical Utilities COP Steering Committee, Cohen has been a contributing author to the ISPE Baseline Guide for Water and Steam Systems and the ISPE Good Practice Guide on Commissioning and Qualifiation for Pharmaceutical Water and Steam Systems

  • ISPE Water and Steam Baseline Guide- General Overview of the New 2nd Edition (ISPE- Community of Practice Track)

Sam Taylor, North Carolina Biosciences Organization

  • Age of Uncertainty: Impacts of Policy Turmoil on Life Science Innovation (Quality Track)

Beth Thomas, Novartis

  • Career Fair Tips and the Do’s & Don’ts of Applying for a Job (Career Development Track)

Corporate Sponsors for the 19th Annual ISPE CASA Life Sciences Technology Show