Jordan Collins

A child claims their space in the world with a hopeful response to a complicated question in this lyrical picture book. I am from children of millions of years, a time line of humanity. I am from this planet and all others. When a child is once again on the receiving end of the dreaded question "Where are you from?" their answer takes readers on an intergalactic journey through the cosmos. Traveling across space and time, past collapsing stars and nebulae, the young narrator reminds us not of our differences but of our shared humanity. Debut author Jordan Collins's poetic prose, informed by lived experience, and Phil Lesnie's stunning illustrations create a powerful story that celebrates our intricate and beautiful connections with one another. End notes from author and illustrator relay more about the experiences both have had in fielding a question that may be familiar to many young readers.

A passionate, personal and political picture book that calls out racism from an important new voice, illustrated by the acclaimed artist of Feathers.

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validationlifecycle approach. This set is published as a comprehensive solution for solid dose process validation.

Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.