Fremont, California (PressExposure) March 22, 2013 -- Description:
Validation is not where atest method or manufacturing process ends. After this has been done, there is a need to continuously demonstrate that the procedure will operate consistently and reproducibly in a manner that meets the validation requirements.
That the FDA expects continuous process verification is shown in the recent guidance document on process validation. The FDA expects to see continuous process verification employed over the working life of a test method or manufacturing process. Which is the method for doing this? It is the use of Statistical Process Control (SPC) charting, a method that has for some time been recognized as a means for monitoring processes of all types.
This webinar will show how to apply basic SPC to variable data. It will present the rules used in the interpretation of the charts.
It will cover the following areas:
o Background on the use of SPC charts. Walter Shewhart and his ideas
o The standard SPC chart for variables
o A common variant of the standard chart
o The Western Electric Rules for SPC charting
When:April 11, 10:00 AM PDT | 1:00 PM EDT
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 testing skills were honed in the initial years of his career at the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here, he developed expertise in the testing of blood derivatives, viral and bacterial vaccines.
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.
The webinar will benefit
o Regulatory Affairs personnel who prepare the CMC sections of submissions.
o Development personnel who will set the early specifications.
o R & D personnel who will contribute data for use in development.
o Project managers for product development studies.
o Quality systems auditors
Duration: 90 minutes
To enroll for this webinar, contact