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DTSTAMP:20240328T225926Z
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DTSTART:20210406T100000
DTEND:20210407T100000
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DESCRIPTION:Overview:
\nThose who work with process optimization and v
alidation focus on
\noptimizing a process and reducing variability. T
hose working on Test
\nMethod Validation\, on the other hand\, focus
on discerning between
\nprocess variation and measurement error from
the test method itself.
\n
\nWhy should you Attend:
\nThis
webinar will help you better understand Test Method Validations
\nto
verify the performance of a Medical Device\, global reference
\nstand
ards\, the FDA requirements and how to perform successful TMV
\nto en
sure your inspection of verification is effective\, using detailed
\n
real-life case studies.
\n
\nAreas Covered in the Session:
\nWhen should Methods be Validated?
\nQualification vs Validation
\nTypes of Test Method Validations
\nHow to perform successful test
method validations
\n
\nWho Will Benefit:
\nManufacturing
Engineers
\nRegulatory Affairs Teams
\nQuality Assurance &\;
Quality Control Teams
\nOperations Teams
\nDocument Control
\n
\nSpeaker Profile:
\nJose Mora is a Principal Consultant spe
cializing in Manufacturing
\nEngineering and Quality Systems. For ove
r 30 years he has worked
\nin the medical device industry specializin
g in manufacturing\, process
\ndevelopment\, tooling\, and quality sy
stems. Prior to working full time
\nas a consulting partner for Atzar
i Consulting\, Jose served as Director
\nof Manufacturing Engineering
at Boston Scientific and as Quality
\nSystems Manager at Stryker Ort
hopedics\, where he introduced
\nprocess performance\, problem solvin
g\, and quality system
\nmethodologies.
\n
\nEvent Fee: One
Dial-in One Attendee Price: US $150.00
\n
\nContact Detail:
\nCompliance4All DBA NetZealous\,
\nPhone: +1-800-447-9407
\nE
mail: compliance4all14@gmail.com
SUMMARY:Test Method Validation to Verify the Performance of a Medical Devic
e
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SUMMARY:Test Method Validation to Verify the Performance of a Medical Devic
e
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