ISPE New Jersey Chapter Past Events and Presentations

21 April 2011

ISPE Presentation

Impact on Drug Delivery on Modern Medicine
Dr. Waseem Malick, Vice President of Pharmaceutical and Analytical Research and Development, Hoffman-La Roche
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16 February 2011

Filling Line Validation Workshop

Tour of an Aseptic Filling Line
Dragutin Stoicovici, Director of Quality, Cozzoli Machine Company
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Validation Workshop
Paul Melamud, QPharma
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14 October 2010

Dual Track Event

Data Center Design
Ronald Szkodny, P.E.
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21 January 2010

ISPE Meeting

C-TPAT
John Tomoney
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October 28, 2009

ISPE Meeting

Solar Renewable Energy - Now
Thomas Leyden, Managing Director
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June 17, 2009

ISPE New Jersey - Chapter Day

New Requirements & Resources for BioProcess Equipment Design
David M. Marks, P.E., ASME BPE Design Subcommittee Chair, President and Senior Consultant
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Process Analytical Technology Examples & Business Case Development
Jonathan Roy
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Green Design as Applied to cGMP Buildings
W. Bruce Eckman, PhD, WBE Consulting
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Draft Revision of FDA Guidance on Process Validation
Chris Ames, Director Global Validation, Catalent Pharma Solutions
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Dynamic Control of Laboratory Air Change Rates Based on Sensing the Lab’s Indoor Environment
Gordon Sharp
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Performance Verification of AEC Downflow Booth via Surrogate Air Monitoring with Lactose Monohydrate
John Kremer of AEC, Hari Floura of Floura LLC
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OSHA Red Flags for Safety
Tom Moon, MS Safety Manager, Torcon, Inc.
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Sustainable Design for Laboratories
Barry Barnet PE, LEED AP
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History of GMPs
Paul A. Melamud, Validation Manager, QPharma, Inc.
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May 10, 2009

FDA’s Role in Plant Design Reviews

Erin D. McCaffery, Investigator, New Jersey District Office

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February 10, 2009

GAMP® 5 – The Risk Based Approach Presentation and Panel Discussion

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