Pack of THREE: Best Selling Statistical Webinars by GlobalCompliancePanel Actual Price:
Using Statistics to Determine Sample Size This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Instructors:
Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to
Steven Walfish President, Statistical Outsourcing Services
ensure a certain level of process capability will be covered.
Statistical Process Control and Trending Analysis There are several methods to trend data to highlight both the preventative and corrective nature of the system. Plotting data over time is a good visual method to identify trends.
Statistical Process Control (SPC) techniques such as control charts give an objective method to identify trends. A discussion of out of trend versus out of specification will be covered.
Statistical Concepts of Process Validation The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process capability. The presentation illustrates the statistical concepts. The Global Harmonization Guidance document on process validation shows the application of statistical techniques.
Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry...more
Dan OLeary President, Ombu Enterprises
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. .. more
Click here to buy the webinar pack Your Necessity is our Priority It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
Published on Sep 19, 2011
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the...