This course takes a balanced approach presenting basic DoE theory as well as numerous examples of DoE use in the pharmaceutical industry. The course will discuss statistical and practical significance, assumptions and limitations of DoE methodology, together with practical approaches for the process scientist to be in control of the DoE investigation (and not the computer).
Precedent and experience compel many chemists to use OVAT experimentation in spite of its incomplete nature, and in spite of its inability to detect factor interactions, e.g., cases when the impact of one factor depends on the level of another factor. When such interactions occur between scale dependent and scale independent factors, ignoring such factor interactions can lead to high risk process scale-up and technology transfer.
Participants will learn how to design effective screening experiments, how to use response surface methods for reaction and analytical method development, how to design robust processes, and how to quantify the risk associated with the implementation of the processes developed. Several commercial DoE software platforms will be reviewed.
For the benefit of process scientists, engineers, formulators*, analytical chemists and manufacturing personnel, this course includes highly interactive, hands-on workshops.
Precedent and experience compel many chemists to use OVAT experimentation in spite of its incomplete nature, and in spite of its inability to detect factor interactions, e.g., cases when the impact of one factor depends on the level of another factor. When such interactions occur between scale dependent and scale independent factors, ignoring such factor interactions can lead to high risk process scale-up and technology transfer.
Participants will learn how to design effective screening experiments, how to use response surface methods for reaction and analytical method development, how to design robust processes, and how to quantify the risk associated with the implementation of the processes developed. Several commercial DoE software platforms will be reviewed.
For the benefit of process scientists, engineers, formulators*, analytical chemists and manufacturing personnel, this course includes highly interactive, hands-on workshops.
