Workshop Overview
Trainer: Isabel Helena
de Brito Manique
The aim of this course is to provide an insight into the pharmaceutical product
and process lifecycle concept.
The foundation for the course is the lifecycle concept to process validation that
links product and process development, qualification/validation of the
commercial manufacturing process, and maintenance of the process in a state of
control during routine commercial production as well as continual improvement
and lifecycle maintenance.
The course combines theory and practical examples on how to use the
fundamental tools: Risk analysis RA, Design of experiments DoE and statistics to
define, validate and monitor the process and improve both, quality and efficiency,
in pharmaceutical plants.
The course will be interactive with a combination of course lectures and
workshops.