Connecting Pharmaceutical Knowledge
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Global News
October 09, 2018By the year 2025, every second new biopharmaceutical product will...October 09, 2018View All NewsBy 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...October 11, 2018With less than a month to go, we are now...October 11, 2018View All NewsWith 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...October 01, 2018David W. McAlonan, BSChE, MBA Retired Retired Dave McAlonan joined...October 01, 2018View All NewsDavid 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...September 24, 2018Have you tried designing an ATMP manufacturing facility and found...September 24, 2018View All NewsHave 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
November04
2018 ISPE Annual Meeting & Expo
2018 ISPE Annual Meeting & Expo Global Regulatory Participation Andrea...Philadelphia Convention Center
November 04, 2018View All Events2018 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...November08Quality Management Systems Training Course
The Pharmaceutical Quality System (PQS), supported by ICH Q10, is...November 08, 2018View All CoursesThe 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,...November08Commissioning and QualificationFacilitiesFacilities Management Training Course
The successful delivery of manufacturing facilities regulated by various authorities,...November 08, 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...November08FacilitiesProject ManagementPharma Facilities Project Management Training Course
This classroom course aims to deliver more than the usual...November 08, 2018View All CoursesThis 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... -
Most Popular
September 10, 2018Facilities and Equipment is a very broad track intended to...September 10, 2018View All NewsFacilities 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...September 12, 2018New terms in the biopharma realm rarely surprise us but...September 12, 2018View All NewsNew 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...September 20, 2018BioMarin Pharmaceuticals is the 2018 Facility of the Year ®...September 20, 2018View All NewsBioMarin 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...
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...
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 -
Japan Affiliate: Pest Control Manual
Japan Affiliate: Pest Control Manual
Publication Date: August 2018
Pages: 180 -
Baseline Guide Vol 3: Sterile Product Manufacturing Facilities
Baseline Guide Vol 3: Sterile Product Manufacturing Facilities
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
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...