Italy Affiliate

Global News

October 09, 2018

What’s New & Highlights for the 2019 ISPE Aseptic Conference

By the year 2025, every second new biopharmaceutical product will...

October 09, 2018

By the year 2025, every second new biopharmaceutical product will be considered highly potent and/or toxic with the oncology sector driving the growth. Highly potent/toxic products are a new generation...

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October 11, 2018

Hot Topics & Trends in Pharma Quality Systems & Regulatory Efforts

With less than a month to go, we are now...

October 11, 2018

With less than a month to go, we are now working with our industry and regulatory colleagues to finalize the sessions for the Quality Systems and Regulatory Track for the...

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October 01, 2018

Member Spotlight – Dave McAlonan

David W. McAlonan, BSChE, MBA Retired Retired Dave McAlonan joined...

October 01, 2018

David W. McAlonan, BSChE, MBA Retired Retired Dave McAlonan joined ISPE in 1988 and recently retired from AbbVie, formerly Abbott Labs. Dave has been a Great Lakes Chapter leader and...

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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 Global Regulatory Participation Andrea...

Philadelphia Convention Center

November 04, 2018

2018 ISPE Annual Meeting & Expo Global Regulatory Participation Andrea R. Cornelio Geyer, MSc Senior GMP Inspector and Expert Regulatory Advisor Office of Pharmaceutical Inspections-Brazilian Health Regulatory Agency (ANVISA) ANVISA...

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November

08

Quality Management Systems Training Course

The Pharmaceutical Quality System (PQS), supported by ICH Q10, is...

November 08, 2018

The Pharmaceutical Quality System (PQS), supported by ICH Q10, is the key foundation on which product realization depend. Through lecture and group exercises this course illustrates how quality systems work,...

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November

08

Commissioning and Qualification

Facilities

Facilities Management Training Course

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

November 08, 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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November

08

Facilities

Project Management

Pharma Facilities Project Management Training Course

This classroom course aims to deliver more than the usual...

November 08, 2018

This classroom course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing...

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Most Popular

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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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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Guidance Documents

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GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

Published: October 2018
Pages: 196
Bound version ships after 26 October 2018

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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

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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

See More Documents

ISPE Blog

Hot Topics & Trends in Pharma Quality Systems & Regulatory Efforts

October 11, 2018

What’s New & Highlights for the 2019 ISPE Aseptic Conference

October 09, 2018

Member Spotlight – Dave McAlonan

October 01, 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

Italy Affiliate

2018 ISPE Annual Meeting & Expo

Quality Management Systems Training Course

Facilities Management Training Course

Pharma Facilities Project Management Training Course

GAMP 5 Guide: Compliant GxP Computerized Systems

Guidance Documents

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

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

ISPE Blog