We provide a complete toolkit for you to easily host a successful...
13 February, 2019
We provide a complete toolkit for you to easily host a successful event
The Women in Pharma® toolkit is ready to help you host an event for your ISPE affiliate or chapter. In...
Making clinical trials more patient centric is among the many cha...
12 February, 2019
Making clinical trials more patient centric is among the many challenges facing the pharmaceutical industry. One method of improving the patient experience is by delivering st...
ISPE has been honored as the winner of four 2018...
February 11, 2019
ISPE has been honored as the winner of four 2018 Annual Service Industry Awards (SIAA). The SIAA program recognizes service industries for their creativity, excellence, and influential achievements in marketing...
Conference Essentials
Conference AgendaTravel Tips
Registration and Information Hours
Thursday, 7 February | 0700–1800
Friday, 8 February | 0700–1430
Exhibit Hall Hours
T...
International Women's Day Executive Panel Discussion - Celebrating Women, Presented by Women, Open to Men and Women
Join us in Celebrating the 1st Annual International Women's Day...
Eureka Building
March 07, 2019
Join us in Celebrating the 1st Annual International Women's Day Executive Panel Discussion Celebrating Women, Presented by Women Open to Men and Women Thursday, March 7, 2019 5:00pm - 7:30pm...
Good Practice Guide: Applied Risk Management for C&Q
Published: October 2011 Pages: 140 Table of Contents Special Pricing for Emerging Economies The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification describes how organizations can move...
GAMP Good Practice Guide: Electronic Data Archiving
Published: July 2007 Pages: 152 Table of Contents Special Pricing for Emerging Economies This Guide provides a rational and scaleable approach to electronic data archiving through the development of an...
GAMP Good Practice Guide: Operation of GxP Computerized Systems
Published: January 2010 Pages: 216 Table of Contents Special Pricing for Emerging Economies During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness...
Good Practice Guide: Decommissioning Pharma Equipment & Facilities
Published: June 2017 Pages: 132 Table of Contents Special Pricing for Emerging Economies Decommissioning is a general term for a process to remove something from active status. It may be...
Good Practice Guide: Technology Transfer 3rd Edition
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated.
Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation.
GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated organization.
In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.
The ISPE Japan Affiliate Manual on Pest Control expands on the concepts and policies set forth in the previous ISPE Japan Affiliate Handbook on Pest Control (English Translation, version 4) and offers advice for new and aging GMP facilities. It proposes plans for incorporating pest control best practices into the project schedule for new construction, including advice on integrating pest control requirements during all phases of construction, training construction staff, and determining areas to inspect both during and at the end of construction.
Pharmaceutical Engineering magazine’s March–April 2016 Special Report 1 highlighted the increasing importance of data integrity for companies throughout the global GMP-regulated industry. This is especially true during health authority inspections. 2 , 3 , 4...