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DTSTART:19700308T020000
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UID:2140535:Event:81905
DTSTAMP:20260531T044525Z
SUMMARY:Medical Devices - Complying With 820.250 Statistical Methods
DESCRIPTION:Overview\n\nLearn how to manage Statistics including estab
 lishing a policy along with procedures relative to specific areas of a
 pplications.\nHighlighted are statistical techniques for:\n\nProcess V
 alidation\nDesign Verification\nDesign Validation\nAudits and Effectiv
 eness Checks\nTest Method Validation\nManufacturing Acceptance Samplin
 g Plans and Inspections\nTrending Data\nSetting Specifications\n\n \n
 Numerous badly needed advances in the application of statistics have o
 ccurred over the last 10-20 years. This are highlighted including:\n\n
 Change-Point Analysis for CAPA Investigations and Trending\nNormalized
  I and Laney U charts for complaint trending\nEquivalency testing inst
 ead of t-tests\nMethods of Validating Attribute and Destruction Test M
 ethods\nImproved methods for testing for and handling nonnormal data\n
 Sampling Plans for precision, accuracy, and homogeneity\n\n\nWhy shoul
 d you Attend\n\nTwo of common 483 and Warning letter items are:\n\nLac
 k of valid statistical rationale\nInadequate trending of Quality data\
 n\nLearn how to avoid these and how to fully comply with the statistic
 al regulations\nThe majority of 483s and Warning letters are associate
 d with lack of or inadequate procedures. Every section of 820 that men
 tions statistics includes a reference to a procedure. Learn how to str
 ucture your statistical procedures to ensure compliance. \n\nAreas Co
 vered in the Session\n\n\nImportance of a Statistical Policy\nNeeded p
 rocedures for areas of establishing, controlling and verifying\nImport
 ant elements for each procedure\nValid statistical rational\nStructuri
 ng the procedures to reduce the training burden\nDeviating from proced
 ures\nHandling when there is not a procedure\n\n\nWho Will Benefit\n\n
 \nCorporate and Division Management\nRegulatory Management and Personn
 el\nInternal Auditors\nQA/QC Engineers and Management\nProcess Enginee
 rs and Management\nDesign Engineer and Management\nStatisticians\n\n\n
 For more information visit https://medtechiq.ning.com/events/medical-d
 evices-complying-with-820-250-statistical-methods-1
DTSTART;TZID=America/New_York:20190204T100000
DTEND;TZID=America/New_York:20190204T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.traininng.com/webinar/medical-devices---complying-
 with-820.250-statistical-methods-200522live?medtechiq_seo
URL:https://www.traininng.com/webinar/medical-devices---complying-with
 -820.250-statistical-methods-200522live?medtechiq_seo
CONTACT:(510) 962-8903
ORGANIZER:Traininng.com LLC
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/702424968?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Joseph W
 ilcox":https://medtechiq.ning.com/profile/JosephWilcox
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