The Netherlands Affiliate

Global News

July 11, 2018

Realizing Transformational Technologies in Regulated Pharma World

Information Systems Track at the 2018 ISPE Annual Meeting &...

July 11, 2018

Information Systems Track at the 2018 ISPE Annual Meeting & Expo Fantastic, isn’t it! Information technologies are evolving at such a pace that it seems there is something new to...

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April 24, 2018

Get Ready for Pharma 4.0 - Highlights 2018 ISPE Europe Annual Conference

A record-setting 640 attendees gathered in Rome in March for...

April 24, 2018

A record-setting 640 attendees gathered in Rome in March for the 2018 ISPE Europe Annual Conference . More than 70 sessions offered the latest thinking on topics including facilities of...

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Submit Your Facility

Has your company recently designed, built or renovated a state-of-the-art pharmaceutical or biotechnology facility that is best in its class? Submit an entry into the 2019 ISPE Facility of the...

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ISPE International Honor Awards

Each year, ISPE pays tribute to exceptional efforts put forth by Volunteers through special recognition as determined by the International Honor Awards Committee. Those recognized include individual Volunteers, Affiliates and Chapters, Students, and the Company of the Year.

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Global Events

November

04

Conference

2018 ISPE Annual Meeting & Expo

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

Pennsylvania Convention Center

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...

Event Details

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September

10

GAMP®

GAMP Data Integrity 21 CFR Part 11 Training Course

The importance and amount of data being generated to ensure...

September 10, 2018

The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies...

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September

13

Commissioning and Qualification

Facilities

Quality Assurance for Facilities Management Training Course

The successful delivery of manufacturing facilities regulated by various authorities,...

September 13, 2018

The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. This interactive classroom course will provide the learner with tools...

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September

17

Cleaning

Validation

Cleaning Validation Principles Training Course

As cleaning technology and detection methodology advance, so do the...

September 17, 2018

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program.

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Most Popular

November

04

Conference

2018 ISPE Annual Meeting & Expo

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

Pennsylvania Convention Center

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...

Event Details

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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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Classroom Training Opportunities

ISPE's interactive, world-class training keeps you up-to-date on changes in your industry—featuring lectures, case studies, complimentary guidance documents, and group exercises. Limited seats are available for our most popular training courses in Amsterdam in September including:

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

Read Full Description

See More Documents

ISPE Blog

Realizing Transformational Technologies in Regulated Pharma World

July 11, 2018

Surrounding & Controlling Underground Leaks in Pharma Facilities & Equipment Part 2

July 09, 2018

Patient-Focused Harmonization Efforts - ISPE Quality Manufacturing Conference

July 05, 2018

View ISPE Blog

July 2018

IN THIS ISSUE Cover: The Fourth Industrial Revolution Technology is advancing faster than ever. Rapid, major changes are on the horizon for just about...

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Upcoming Issues

The Netherlands Affiliate

Realizing Transformational Technologies in Regulated Pharma World

Get Ready for Pharma 4.0 - Highlights 2018 ISPE Europe Annual Conference

Submit Your Facility

ISPE International Honor Awards

2018 ISPE Annual Meeting & Expo

GAMP Data Integrity 21 CFR Part 11 Training Course

Quality Assurance for Facilities Management Training Course

Cleaning Validation Principles Training Course

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

Classroom Training Opportunities

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

Realizing Transformational Technologies in Regulated Pharma World

Surrounding & Controlling Underground Leaks in Pharma Facilities & Equipment Part 2

Patient-Focused Harmonization Efforts - ISPE Quality Manufacturing Conference