Medical Devices - Complying With 820.250 Statistical Methods
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Category Online Professional Trainings;world class professionals trainings;professionals training courses:medical devices online training
Deadline: February 28, 2019 | Date: March 01, 2019
Venue/Country: Online, U.S.A
Updated: 2019-01-09 16:12:41 (GMT+9)
Call For Papers - CFP
OverviewLearn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications.Highlighted are statistical techniques for:Process ValidationDesign VerificationDesign ValidationAudits and Effectiveness ChecksTest Method ValidationManufacturing Acceptance Sampling Plans and InspectionsTrending DataSetting SpecificationsNumerous badly needed advances in the application of statistics have occurred over the last 10-20 years. This are highlighted including:Change-Point Analysis for CAPA Investigations and TrendingNormalized I and Laney U charts for complaint trendingEquivalency testing instead of t-testsMethods of Validating Attribute and Destruction Test MethodsImproved methods for testing for and handling nonnormal dataSampling Plans for precision, accuracy, and homogeneityWhy should you AttendTwo of common 483 and Warning letter items are:Lack of valid statistical rationaleInadequate trending of Quality dataLearn how to avoid these and how to fully comply with the statistical regulationsThe majority of 483s and Warning letters are associated with lack of or inadequate procedures. Every section of 820 that mentions statistics includes a reference to a procedure. Learn how to structure your statistical procedures to ensure compliance. Areas Covered in the SessionImportance of a Statistical PolicyNeeded procedures for areas of establishing, controlling and verifyingImportant elements for each procedureValid statistical rationalStructuring the procedures to reduce the training burdenDeviating from proceduresHandling when there is not a procedureWho Will BenefitCorporate and Division ManagementRegulatory Management and PersonnelInternal AuditorsQA/QC Engineers and ManagementProcess Engineers and ManagementDesign Engineer and ManagementStatisticians
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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