Business Knowledge Series course
Presented by Heath Rushing, co-founder and Principal Consultant, Adsurgo LLC; or Richard Burdick, Ph.D., Professor Emeritus Arizona State University and Chief Statistician, Elion Labs
The pharmaceutical industry relies on analytical procedures for the combined practices of process and formulation development, process validation, and manufacturing, as well as both in-process and final-product testing. These test methods need not only to be validated; the test methods need to be both reliable and fit for their intended use. This course provides a systematic approach to the life cycle of analytical procedures that begins in procedure design and development, continues in procedure performance qualification, and is maintained in continued procedure performance verification.
Learn how to
- Apply a Quality by Design (QbD) approach throughout the life cycle of an analytical procedure.
- Reference legal and regulatory documents for requirements associated with analytical validation.
- Describe the principles of analytical validation that are referenced by those legal and regulatory documents.
- Set analytical procedure validation requirements that are fit for their intended use.
- Apply the statistical tools for QbD throughout the life cycle of an analytical procedure.
Who should attend
Scientists who need to apply sound science and statistical and quality risk management methods in validation and throughout the life cycle of an analytical procedure
There are no prerequisites. However, you are highly encouraged to attend the following courses:
This course addresses JMP software.
