Connecting Pharmaceutical Knowledge
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Global News
June 18, 2018This article was originally published in the March April issue...June 18, 2018View All NewsThis 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...
GAMPGAMP 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...
GAMP Good Practice GuidesGAMP 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...
GAMP Good Practice GuidesGAMP 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... -
Global Events
November04
2018 ISPE Annual Meeting & Expo
2018 ISPE Annual Meeting & Expo Hear first-hand from attendees...Philadelphia Marriott Downtown
November 04, 2018View All Events2018 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...September13Commissioning and QualificationFacilitiesQuality Assurance for Facilities Management Training Course
The successful delivery of manufacturing facilities regulated by various authorities,...September 13, 2018View All CoursesThe 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...September17CleaningValidationCleaning Validation Principles Training Course
As cleaning technology and detection methodology advance, so do the...September 17, 2018View All CoursesAs 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...June07Commissioning and QualificationFacilitiesCommissioning and Qualification Training Course
Through interactive workshops, this course will explain and apply the...June 07, 2018View All CoursesThrough 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,... -
Most Popular
November04
2018 ISPE Annual Meeting & Expo
2018 ISPE Annual Meeting & Expo Hear first-hand from attendees...Philadelphia Marriott Downtown
November 04, 2018View All Events2018 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...
GAMPGAMP 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...September24GAMP®GAMP 5, Annex 11/Part 11 Basic Principles Training Course
This Classroom training course has been updated to include the...September 24, 2018View All CoursesThis 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...March 14, 2018ISPE announced the speaker line-up for their 2018 Continuous Manufacturing...March 14, 2018View All NewsISPE 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.
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 -
GAMP Good Practice Guide: Computerized GCP Systems & Data
GAMP Good Practice Guide: Computerized GCP Systems & Data
Published: December 2017
Pages: 128 -
GAMP Good Practice Guide: IT Infrastructure Control and Compliance
GAMP Good Practice Guide: IT Infrastructure Control and Compliance
Published: August 2017
Pages: 168 -
Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products
Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products
ISPE Blog
May 2018
IN THIS ISSUE Cover: The Rise of Biopharmaceutical Manufacturing in Asia Biopharmaceuticals are booming in Asia, buoyed by enhanced regulations, an in...