The Netherlands Affiliate

Global News

September 10, 2018

Resource to Address Challenges in Pharma Facilities & Equipment

Facilities and Equipment is a very broad track intended to...

September 10, 2018

Facilities and Equipment is a very broad track intended to challenge those involved in the delivery of pharmaceutical facilities used to support the development, manufacturing, testing, and storage of pharmaceutical...

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September 12, 2018

What are Oligonucleotides?

New terms in the biopharma realm rarely surprise us but...

September 12, 2018

New terms in the biopharma realm rarely surprise us but keeping up with the technology and the means of manufacturing can often be challenging. What I really enjoy about ISPE...

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September 20, 2018

Meet BioMarin Pharmaceuticals, Inc – 2018 FOYA Project Execution Category Winner

BioMarin Pharmaceuticals is the 2018 Facility of the Year ®...

September 20, 2018

BioMarin Pharmaceuticals is the 2018 Facility of the Year ® Project Execution Category Winner for their Project FAITH site in Novato, CA. Projects selected in this category exemplify the application...

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September 24, 2018

Regulatory Guidance for Designing an ATMP Manufacturing Facility

Have you tried designing an ATMP manufacturing facility and found...

September 24, 2018

Have you tried designing an ATMP manufacturing facility and found the lack of regulatory guidance challenging and even frustrating. I recently had such an experience. Advanced Therapy Medicinal Products (ATMPs)...

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Global Events

November

04

Conference

2018 ISPE Annual Meeting & Expo

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

Philadelphia 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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October

01

Facilities

GMP Sterile Pharmaceutical Manufacturing Facility Training Course

This classroom course uses the second edition of the ISPE...

October 01, 2018

This classroom course uses the second edition of the ISPE Baseline ® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing...

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October

01

Facilities

HVAC

HVAC cGMP Regulations Training Course

This classroom course focuses on common issues and problems in...

October 01, 2018

This classroom course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction...

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October

03

Commissioning and Qualification

Facilities

Commissioning and Qualification Training Course

Through interactive workshops, this course will explain and apply the...

October 03, 2018

Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9,...

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Most Popular

August 29, 2018

Getting on the Six Sigma Path to Quality

2018 ISPE Continuous Manufacturing Workshop Disclaimer: This article contains brief,...

August 29, 2018

2018 ISPE Continuous Manufacturing Workshop Disclaimer: This article contains brief, abridged, and informal synopses of remarks from a US FDA regulator during the 2018 ISPE Continuous Manufacturing Workshop proceedings in...

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August 27, 2018

New Technologies & Molecules: Ready for the Future of Biologics Manufacturing?

If you want to prepare yourself for the next 10...

August 27, 2018

If you want to prepare yourself for the next 10 years of your career, then I invite you to join me at this year's 2018 ISPE Biopharmaceutical Manufacturing Conference ,...

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August 24, 2018

Meet Shire – 2018 FOYA Facility Integration Category Winner

Shire is the 2018 FOYA Facility Integration Category Winner for...

August 24, 2018

Shire is the 2018 FOYA Facility Integration Category Winner for their Los Angeles Master Plan Building 8 Project in Los Angeles, California. Winners in this category exemplify the application of...

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December 03, 2015

GAMP: Administrators for Instruments – Your Administrator Part 2

By: Mark Newton, Associate Sr. Consultant - QA, Global Quality...

December 03, 2015

By: Mark Newton, Associate Sr. Consultant - QA, Global Quality Laboratories for Eli Lilly and Company Previously we discussed the importance of selecting the right person as your administrator to...

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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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Japan Affiliate: Pest Control Manual

Japan Affiliate: Pest Control Manual

Publication Date: August 2018
Pages: 180

Table of Contents

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Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

Published: April 2018
Pages: 244

Table of Contents

Read Full Description
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

See More Documents

ISPE Blog

Regulatory Guidance for Designing an ATMP Manufacturing Facility

September 24, 2018

Meet BioMarin Pharmaceuticals, Inc – 2018 FOYA Project Execution Category Winner

September 20, 2018

What are Oligonucleotides?

September 12, 2018

View ISPE Blog

September 2018

IN THIS ISSUE Cover: The first revision to Annex 1 in a decade has rebuilt and reorganized the document to align with GMP in Europe. New sections on s...

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Upcoming Issues

The Netherlands Affiliate

2018 ISPE Annual Meeting & Expo

GMP Sterile Pharmaceutical Manufacturing Facility Training Course

HVAC cGMP Regulations Training Course

Commissioning and Qualification Training Course

Classroom Training Opportunities

Guidance Documents

Japan Affiliate: Pest Control Manual

Japan Affiliate: Pest Control Manual

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

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

ISPE Blog