This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. A practical approach with case studies and examples will be used,
with theoretical information introduced only when necessary to understand an experiment. Examples from real processes and testing procedures will be used to present the student with examples that will be directly applicable to their work.
Who Will Benefit:
- Lead workers in Process Development
- Regulatory Affairs
- Quality Assurance and Quality Control
- Workers who will be participating in operations or the supervision of the development, manufacturing, or testing of medicinal products will benefit from knowing the procedures and applications of DOE and SPC.
Why you should attend:
Any pharmaceutical worker who performs, supervises or reviews manufacturing or testing processes needs to understand the relationships among the process parameters and be able to monitor the performance of processes and test methods. This is particularly true for the worker in Quality Control and Quality Assurance as the recent FDA guidance document on Process Validation has assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit. The work, however, is done by the development, manufacturing, or quality systems worker who should also attend this course to learn how to design the systems and studies, and interpret the results generated.