subject: Statistical Procedures Needed For Compliance With The Guidance On Process Validation [print this page] RAPS pre-approved webinar on Statistical Procedures Needed for Compliance with the Guidance on Process Validation from GlobalCompliancePanel
Description:The FDA recently issued a new guideline on process validation. Although it is not expected to be dramatically different from the existing one; it is going to supersede the existing guideline. Also, some of these guidelines are expected to be of an advanced nature, which makes it imperative for companies to be aware of and be prepared to implementthese. Statements from the new guideline have sufficiently hinted that statistical procedures are to be expected.
In light of this new guideline, some of the areas that professionals in process validation need to be familiar with are:
oIn general, what topics does the new draft guidance cover?
oWhat are the specific statements?
oWhat are these statistical procedures, and how are we expected to apply them?
oIf we lack statistical expertise, what can we do to ensure compliance?
This webinar tackles these questions and helps participants understand and implement these new nuances.
By whom:Steven S. Kuwahara, Ph.D., is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. After securing degrees in Biochemistry from Cornell and the University of Wisconsin, Steven started off as an Assistant Professor of Chemistry.
His work has also dealt with all aspects of GMP and GLP in relation to biopharmaceuticals. He has worked with small molecules, proteins, cells, and gene therapy vectors.
During an impressive career spanning over 30 years, Steven has applied his academic knowledge to quality control in the pharmaceutical industry. Steven has written several papers and book chapters, and serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.
