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21 April 2011
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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
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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
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Dual Track Event
Data Center Design
Ronald Szkodny, P.E.
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21 January 2010
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ISPE Meeting
C-TPAT
John Tomoney
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October 28, 2009
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ISPE Meeting
Solar Renewable Energy - Now
Thomas Leyden, Managing Director
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June 17, 2009
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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
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FDA’s Role in Plant Design Reviews
Erin D. McCaffery, Investigator, New Jersey District Office
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February 10, 2009
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GAMP® 5 – The Risk Based Approach Presentation and Panel Discussion
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May 20, 2008
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DUAL TRACK
Holiday Inn, Somerset, NJ
Continuing Evolution of The Pharmaceutical Industry:Career Challenges and Opportunities ( 212 KB)
Going Beyond the Energy Audit: Energy Reduction Strategies for Pharmaceutical and Biotech Companies ( 550 KB)
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April 17, 2008
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ASTM Standard E2500 Overview and Applications Event
Bristol Myers Squibb, New Brunswick, NJ
ISPE’S C&Q COMMUNITY OF PRACTICE (C&Q COP) ( 201 KB)
Applying ASTME2500 BMS Assessment Experience ( 336 KB)
Antonio Crincoli, PE
Commissioning & Validation -the New ASTM Standard ( 892 KB)
David E. Petko, PE
Update on Commissioning and Qualification Standards and Guidance ASTM E 2500 ( 377 KB)
Steve Wisniewski
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February 21, 2008
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Clean Room Overview and Comparison of FDA and EU Regulations
Kumar Gupta, VP Pharmaceutical and Biotechnology, Parsons
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Jan 17, 2008
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Effective Use of Commissioning on Projects
Vincent Wieczorek-Bristol-Myers Squibb
Joseph Lukas-PMK Group, Inc.
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December 2007
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The Continuing Evolution of the Pharmaceutical Industry:
Career Challenges and Opportunities
Regent Atlantic Pharma Papers
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November 15, 2007
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New Perspectives on Cleaning Validation: Science and Risk Based Approaches
Andy Walsh-Clean6Sigma, L.L.C.
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June 13, 2007
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NJ Chapter Day
New Developments in the Design & Construction of Pharmaceutical Facilities
W. Bruce Eckman Torcon, Inc.
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Pharmaceutical cGMP’s for the 21 for the 21st st Century:
A Risk-Based Approach to Pharmaceutical Water System Design
Joe Manfredi, GMP Systems, Inc.
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Strategies for an Integrated Energy Approach
Ed Liberty, Vice President, The Dome-Tech Group
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PwC Health Research Institute: Recapturing the Vision
Peter Claude and Brian Riewerts, PricewaterhouseCoopers
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Surface Finish Basics for Stainless Steel
Bruce Smith, SPX Process Equipment
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What's New at NJDEP
Merwin Kinkade, CHMM, President, Viridian® Inc., Environmental Consultants
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Pyschrometric Sample Problem
Scott T. Smith, P.E., EMCOR Services New York/New Jersey
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Review of GAMP Requirements for Validation – a Risk-Based Approach
Chris Roerig, CQS Innovation and Terrance Petro, Bosch Packaging Technology
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June 15, 2006
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New Jersey Chapter Day
Career Planning Over 40: Do's & Dont's - Thirty Hot Tips! ( 34 KB)
Risk Based Validation of Computer Systems ( 177 KB)
Solid Dosage Process Technologies ( 2 MB)
An FDA Update ( 209 KB)
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October 13, 2005
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Managing Your Rising Energy Costs
Presentation ( 1 MB)
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September 15, 2005
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Water Purification - from the Basics to the Future of the Technologies
Chemistries and Physics of Water Purification ( 2 MB)
Water System Design Planning and Practices ( 181 KB)
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June 16, 2005
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NJ Chapter Day
Session A2 Part1: Spread Spectrum Wireless Technology in Industrial Environments ( 2 MB)
Session A2 Part2: Frequency Hopping and Interference ( 988 KB)
Session A4 - Commissioning & Validation of Process Control Systems ( 2 MB)
Session A5 - On-Line Analyzers ( 203 KB)
Session B3 - Washers/Autoclaves Commissioning/Qualification ( 145 KB)
Session B4 - How Processing Steps and Conditions Affect Agitator Design ( 744 KB)
Session B5 - Integration of High Containment Synthesis Suites ( 2 MB)
Session B6 - Project Management - Improve Your Negotiating Skills! ( 177 KB)
Session C2 - Green Building Design for Research Facilities, Steve Eber Presentation ( 3 MB)
Session C2 - Green Building Design for Research Facilities, Steve Eber Whitepaper ( 168 KB)
Session C2 - Green Building Design for Research Facilities, Lisa Westerfield Presentation ( 1 MB)
Session C3 - Energy Optimization for Pharmaceutical Facilities ( 580 KB)
Session C4 - Designing a CIP System with an Eye Toward PAT ( 1 MB)
Session C5 - QC High Purity Tubing ( 142 KB)
Session C6 - Passivation / Rouge ( 1 MB)
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April 14, 2005
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Isolator Technology - Roundtable Discussion
Presentation ( 479 KB)
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February 10, 2005
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Use of 6 Sigma in Outsourcing Quality Functions
Presentation ( 148 KB)
SIPOC Template for Presentation ( 79 KB)
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