BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:78640
DTSTAMP:20260522T222632Z
SUMMARY:Webinar On \"Scrutinizing Test Method Validation (TMV) to Veri
 fy the Performance of a Medical Device\"
DESCRIPTION:\nDescription :\nTest method validation is an often-confus
 ing requirement for medical devices. A fundamental issue is the role-r
 eversal between the test method and the product or process it is desig
 ned to detect. For example, while a defect-free process is desirable, 
 a test method must be reliable both in detecting defects and in not re
 jecting acceptable samples. Those who work with process optimization a
 nd validation focus on optimizing a process and reducing variability. 
 Those working on Test Method Validation, on the other hand, focus on d
 iscerning between process variation and measurement error from the tes
 t method itself.  This webinar will help you better understand Test Me
 thod Validations to verify the performance of a Medical Device, global
  reference standards, the FDA requirements and how to perform successf
 ul TMV to ensure your inspection of verification is effective, using d
 etailed real-life case studies.\nWhy\n\n\n\n\nAreas Covered in the Ses
 sion :\n\nTest Method Validation - Overview\nQuality System Regulation
 , 21 CFR Part 820, and ISO 13485 - Overview\nWhen should Methods be Va
 lidated?\nQualification vs Validation\nTypes of Test Method Validation
 s\nHow to perform successful test method validations\nHow to ensure yo
 ur inspection of verification is effective\nDetailing real-life case s
 tudies\nUnderstanding global reference standards for test method valid
 ation\nFDA requirements for TMV\nRecommendations: Some Best Practices 
 and Strategies\n\n\n\n\n\nWho Will Benefit:\nManagers, Supervisors, Di
 rectors, and Vice-Presidents in the areas of:\nResearch & Development\
 nQuality Engineers and Auditors\nManufacturing Engineers\nRegulatory A
 ffairs Teams\nQuality Assurance & Quality Control Teams\nOperations Te
 ams\nDocument Control\nDesign Assurance Teams\nDevice Development Team
 s\n\n\n\n\n\nAbout Speaker:\nJosé Mora is a Principal Consultant and 
 Project Manager specializing in Manufacturing Engineering, Quality Sys
 tems, and Lean Transformations. José is a recognized subject matter e
 xpert in process validation, lean manufacturing, lean controlled docum
 ent systems, startup operations, process development and quality syste
 ms, having lectured internationally and presented webinars on these su
 bjects.For over 30 years he has worked in the life sciences in positio
 ns ranging from Senior Engineer and Project Manager to Vice-President,
  specializing in manufacturing, process development, tooling, and qual
 ity systems.\n\n\n\n\n\n\nFor more information visit https://medtechiq
 .ning.com/events/webinar-on-scrutinizing-test-method-validation-tmv-to
 -verify-the
DTSTART;TZID=America/New_York:20180306T130000
DTEND;TZID=America/New_York:20180306T143000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:http://bit.ly/2GMcwwV
URL:http://bit.ly/2GMcwwV
CONTACT:1-844-216-5230
ORGANIZER;CN="Sam Miller":https://medtechiq.ning.com/profile/SamMiller
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562017596?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
END:VEVENT
END:VCALENDAR