Live webcast Sampling Plan for Quality Audits
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Website https://compliance2go.com/product/?pid=CP2014-438 |
Edit Freely
Category Medical Device
Deadline: April 19, 2015 | Date: April 20, 2015
Venue/Country: Online, U.S.A
Updated: 2015-03-16 14:54:09 (GMT+9)
Call For Papers - CFP
DESCRIPTIONQuality audits typically involve sampling of records and other documents. When the auditor does this, many questions arise, such as how many records to sample and how many nonconforming records are too many. In fact, there is a more fundamental question about nonconforming records. If a record has, say, three errors does the auditor count it three time (once for each error) or one time as a nonconforming record. Some auditors determine the sample size without using statistical techniques. Is this ever acceptable? Sampling records in an audit is not the same as sampling at incoming inspection; the underlying assumptions are different, so the methods need to change.Areas covered in the seminar:The concepts of sampling when conducting quality auditsThe difference between a nonconformance and nonconformitiesThe use of (non-statistical) convenience samplesUsing standard sampling plans in an auditUsing the binomial distribution to understand audit samplingAn examination of the FDA’s QSIT sampling plansWho will benefit:Quality ManagersAudit ManagersLead Quality AuditorsQuality AuditorsRegulatory Affairs ManagersWhy you should attend:This session examines the issues in audit sampling and provides the answers you need to plan your audit. Participants learn the difference between counting nonconformities and counting nonconformances and which techniques to apply in a quality audit. An audit may need to determine the error rate in a process, or least show that it is not too great. Participants will learn some standard sampling plans as well the reason they work. As an example, participants will analyze the sampling plans the FDA uses as part of the Quality System Technique (QSIT).Webinar includes:An explanation of how to perform the calculations in ExcelQ/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of attendance
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