Italy Affiliate

Global News

Baseline Guides

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

Table of Contents Special Pricing for Emerging Economies - Learn More The ISPE Baseline ® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition provides a scientific risk-based approach, based...

View Product

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...

View Product

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...

View Product

Baseline Guides

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

Published: April 2018 Pages: 244 Table of Contents Special Pricing for Emerging Economies - Learn More The ISPE Baseline ® Guide: Sterile Product Manufacturing Facilities (Third Edition) covers engineering aspects...

View Product
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

View All Events

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...

View Course

View All Courses

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. With the FDA's risk-based regulatory initiatives focusing...

View Course

View All Courses

June

07

Commissioning and Qualification

Facilities

Commissioning and Qualification Training Course

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

June 07, 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,...

View Course

View All Courses
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

View All Events

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...

View Product

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...

View Course

View All Courses

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.

View Article

View All News

Guidance Documents

See More Documents

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

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
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

Saying “Yes” to Opportunity – Women in Pharma

June 20, 2018

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

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...

View Current Issue

Upcoming Issues

Italy Affiliate

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

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

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

2018 ISPE Annual Meeting & Expo

Quality Assurance for Facilities Management Training Course

Cleaning Validation Principles Training Course

Commissioning and Qualification 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

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

Saying “Yes” to Opportunity – Women in Pharma

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

GAMP 5: Past, Present & Future