Guidance Document Special

ISPE Members get 20% off all Guidance Documents onsite, including these brand new releases!*

ISPE Good Practice Guide (GPG): Applied Risk Management for Commissioning and Qualification

This Guide provides direction to industry on the practical application of the “science and risk-based approaches” described in the ICH Q8, Q9, and Q10 quality guidelines. It provides a “road map” for a range of transition strategies for organizations wishing to migrate from traditional approaches toward science- and risk-based approaches.

ISPE Good Practice Guide (GPG): Interactive Response Technology

This Guide describes how to successfully implement this technology to manage key clinical trial activities; particularly expiry date management and program pooling. It also aims to communicate and foster a standardized, industry wide approach to functionality of Interactive Response Technology when used in managing clinical trial supplies.

ISPE Good Practice Guide (GPG): Project Management for the Pharmaceutical Industry

This Guide aims to collate good practices for project management for a wide variety of project types within the pharmaceutical industry. It considers how appropriate tools and techniques can support and promote good project management practices and aims to help to encourage their use within the pharmaceutical industry.

*20% discount applies only to ISPE Members who purchase onsite at Annual Meeting and does not apply to the already discounted PQLI^® Guide Series.