ISPE New Jersey Chapter Past Events and Presentations

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Date

Event & 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
Download Presentation ( 7 MB)

16 February 2011

Filling Line Validation Workshop

Tour of an Aseptic Filling Line
Dragutin Stoicovici, Director of Quality, Cozzoli Machine Company
Download Presentation ( 659 KB)

Validation Workshop
Paul Melamud, QPharma
Download Presentation ( 4 MB)

14 October 2010

Dual Track Event

Data Center Design
Ronald Szkodny, P.E.
Download Presentation ( 278 KB)

21 January 2010

ISPE Meeting

C-TPAT
John Tomoney
Download Presentation ( 3 MB)

October 28, 2009

ISPE Meeting

Solar Renewable Energy - Now
Thomas Leyden, Managing Director
Download Presentation ( 8 MB)

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
Download Presentation ( 702 KB)

Process Analytical Technology Examples & Business Case Development
Jonathan Roy
Download Presentation ( 1 MB)

Green Design as Applied to cGMP Buildings
W. Bruce Eckman, PhD, WBE Consulting
Download Presentation ( 144 KB)

Draft Revision of FDA Guidance on Process Validation
Chris Ames, Director Global Validation, Catalent Pharma Solutions
Download Presentation ( 111 KB)

Dynamic Control of Laboratory Air Change Rates Based on Sensing the Lab’s Indoor Environment
Gordon Sharp
Download Presentation ( 11 KB)

Performance Verification of AEC Downflow Booth via Surrogate Air Monitoring with Lactose Monohydrate
John Kremer of AEC, Hari Floura of Floura LLC
Download Presentation ( 1 MB)

OSHA Red Flags for Safety
Tom Moon, MS Safety Manager, Torcon, Inc.
Download Presentation ( 6 MB)

Sustainable Design for Laboratories
Barry Barnet PE, LEED AP
Download Presentation ( 825 KB)

History of GMPs
Paul A. Melamud, Validation Manager, QPharma, Inc.
Download Presentation ( 632 KB)

May 10, 2009

FDA’s Role in Plant Design Reviews

Erin D. McCaffery, Investigator, New Jersey District Office

Download Presentation ( 1 MB)

February 10, 2009

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

Download Presentation ( 487 KB)

May 20, 2008

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)

April 17, 2008

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

February 21, 2008

Clean Room Overview and Comparison of FDA and EU Regulations
Kumar Gupta, VP Pharmaceutical and Biotechnology, Parsons

Download Presentation ( 3 MB)

Jan 17, 2008

Effective Use of Commissioning on Projects
Vincent Wieczorek-Bristol-Myers Squibb
Joseph Lukas-PMK Group, Inc.

Download Presentation ( 500 KB)

December 2007

The Continuing Evolution of the Pharmaceutical Industry:
Career Challenges and Opportunities

Regent Atlantic Pharma Papers

Download Presentation ( 1 MB)

November 15, 2007

New Perspectives on Cleaning Validation: Science and Risk Based Approaches
Andy Walsh-Clean6Sigma, L.L.C.

Download Presentation ( 5 MB)

June 13, 2007

NJ Chapter Day

New Developments in the Design & Construction of Pharmaceutical Facilities
W. Bruce Eckman Torcon, Inc.
Download Presentation ( 185 KB)

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.
Download Presentation ( 635 KB)

Strategies for an Integrated Energy Approach
Ed Liberty, Vice President, The Dome-Tech Group
Download Presentation ( 1 MB)

PwC Health Research Institute: Recapturing the Vision
Peter Claude and Brian Riewerts, PricewaterhouseCoopers
Download Presentation ( 79 KB)

Surface Finish Basics for Stainless Steel
Bruce Smith, SPX Process Equipment
Download Presentation ( 384 KB)

What's New at NJDEP
Merwin Kinkade, CHMM, President, Viridian® Inc., Environmental Consultants
Download Presentation ( 889 KB)

Pyschrometric Sample Problem
Scott T. Smith, P.E., EMCOR Services New York/New Jersey
Download Presentation ( 418 KB)

Review of GAMP Requirements for Validation – a Risk-Based Approach
Chris Roerig, CQS Innovation and Terrance Petro, Bosch Packaging Technology
Download Presentation ( 487 KB)

June 15, 2006

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)

October 13, 2005

Managing Your Rising Energy Costs

Presentation ( 1 MB)

September 15, 2005

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)

June 16, 2005

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)

April 14, 2005

Isolator Technology - Roundtable Discussion

Presentation ( 479 KB)

February 10, 2005

Use of 6 Sigma in Outsourcing Quality Functions

Presentation ( 148 KB)

SIPOC Template for Presentation ( 79 KB)

For Information, contact:
Ron Dunn, RDgrafx, Chapter Manager
Tel 610-797-8381, Fax 610-351-9135
manager@ispenj.org

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