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Pre-Order Both and Save BIG on the New PQLI Guide Series!

ISPE is pleased to announce the release of a new Guide Series: describing enhanced, quality by design approaches to product realization. This two-part Series is intended to assist in the development and implementation of practical ‘how to’ approaches using the enhanced, quality by design approach supported by sound scientific, engineering, and business principles.

ISPE Members who register for Annual Meeting can purchase both guides in the series for the reduced rate of $145/€115—a savings of $145!*

Part 1: Product Realization using QbD, Concepts and Principles

Part 1 includes the topics of Criticality, Design Space, and Control Strategy and addresses product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches.

Part 2: Product Realization using QbD, Illustrative Example

Part 2 presents the small molecule case study developed by the ISPE PQLI® teams. This case study provides details of the application of the approaches to product and process understanding using quality risk management. Part 2 also refers to the many case studies in the public domain and uses ICH guidelines Q8 (R2), Q9, Q10, together with other relevant ICH guidelines.

*Discount applies to ISPE Members only. Guides may be purchased onsite or online. If you cancel your Conference registration after purchasing the PQLI Guide Series, you will be charged the full price of the Documents. All materials are anticipated to ship by 10 November.

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