New Jersey Chapter

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June 18, 2018

Bringing the Outside In – When a Pharma Factory is Needed in the Future Part 3

This article was originally published in the March April issue...

June 18, 2018

This article was originally published in the March April issue of Pharmaceutical Engineering ® magazine . Catch up on this series by reading: Bringing the Outside In – When a...

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GAMP

GAMP Guide: Records & Data Integrity

Published: March 2017 Pages: 152 Table of Contents Special Pricing for Emerging Economies - Learn More The importance of ensuring data integrity is reflected in guidance, citations, and public comments...

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GAMP Good Practice Guides

GAMP Good Practice Guide: Computerized GCP Systems & Data

Published: December 2017 Pages: 128 Table of Contents Special Pricing for Emerging Economies - Learn More The ISPE GAMP ® Good Practice Guide: Validation and Compliance of Computerized GCP Systems...

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GAMP Good Practice Guides

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Published: August 2017 Pages: 168 Table of Contents Special Pricing for Emerging Economies - Learn More The ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) is...

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chapter Events

July

27

Affiliate/Chapter

Member Appreciation Event - Somerset Patriots Stadium

Join us for a FREE (ISPE NJ Paid) night at...

Somerset Patriots Stadium

July 27, 2018

Join us for a FREE (ISPE NJ Paid) night at the ballpark! ISPE MEMBERS & FAMILY ONLY MEMEBERS AND THEIR FAMILIES are invited to the party deck at the Somerset...

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November

04

Conference

2018 ISPE Annual Meeting & Expo

2018 ISPE Annual Meeting & Expo Hear first-hand from attendees...

Philadelphia Marriott Downtown

November 04, 2018

2018 ISPE Annual Meeting & Expo Hear first-hand from attendees on why the ISPE Annual Meeting & Expo is the must-attend pharmaceutical event of the year. The 2018 ISPE Annual...

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GAMP

GAMP 5 Guide: Compliant GxP Computerized Systems

Published: February 2008 Pages: 356 Table of Contents Supporting Materials Special Pricing for Emerging Economies - Learn More Ten years after its publication, the ISPE GAMP ® 5 Guide: A...

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September

24

GAMP®

GAMP 5, Annex 11/Part 11 Basic Principles Training Course

This Classroom training course has been updated to include the...

September 24, 2018

This Classroom training course has been updated to include the new revised EU GMP Annex 11 , and an update on 21 CFR Part 11 . This three-day fundamental course...

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March 14, 2018

Speakers Announced for 2018 ISPE Continuous Manufacturing Workshop

ISPE announced the speaker line-up for their 2018 Continuous Manufacturing...

March 14, 2018

ISPE announced the speaker line-up for their 2018 Continuous Manufacturing Workshop, taking place in 6–7 June in Arlington, Virginia USA, in conjunction with their 2018 Pharmaceutical Manufacturing Quality Week.

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Guidance Documents

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Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

Published: April 2018
Pages: 244

Table of Contents

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GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: Computerized GCP Systems & Data

Published: December 2017
Pages: 128

Read Full Description
GAMP Good Practice Guide: IT Infrastructure Control and Compliance

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Published: August 2017
Pages: 168

Table of Contents

Read Full Description
Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products

Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products

Table of Contents

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See More Documents

ISPE Blog

Bringing the Outside In – When a Pharma Factory is Needed in the Future Part 3

June 18, 2018

GAMP 5: Past, Present & Future

June 13, 2018

How to Learn About the Pharma Industry & Build a Network of Contacts

June 11, 2018

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May 2018

IN THIS ISSUE Cover: The Rise of Biopharmaceutical Manufacturing in Asia Biopharmaceuticals are booming in Asia, buoyed by enhanced regulations, an in...

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Upcoming Issues

New Jersey Chapter

Bringing the Outside In – When a Pharma Factory is Needed in the Future Part 3

GAMP Guide: Records & Data Integrity

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Member Appreciation Event - Somerset Patriots Stadium

2018 ISPE Annual Meeting & Expo

GAMP 5 Guide: Compliant GxP Computerized Systems

GAMP 5, Annex 11/Part 11 Basic Principles Training Course

Speakers Announced for 2018 ISPE Continuous Manufacturing Workshop

Guidance Documents

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products

Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products

ISPE Blog

Bringing the Outside In – When a Pharma Factory is Needed in the Future Part 3

GAMP 5: Past, Present & Future

How to Learn About the Pharma Industry & Build a Network of Contacts

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