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Test Method Validation to Verify the Performance of a Medical Device
Date
Apr 06, 2021 - 10:00 AM
Link to Website
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
161 Mission Falls Lane, Suite 216,,
Fremont,
California,
United States,
ZIP: 94539
Phone: 8004479407
Overview:
Those who work with process optimization and validation focus on
optimizing a process and reducing variability. Those working on Test
Method Validation, on the other hand, focus on discerning between
process variation and measurement error from the test method itself.
Why should you Attend:
This webinar will help you better understand Test Method Validations
to verify the performance of a Medical Device, global reference
standards, the FDA requirements and how to perform successful TMV
to ensure your inspection of verification is effective, using detailed
real-life case studies.
Areas Covered in the Session:
When should Methods be Validated?
Qualification vs Validation
Types of Test Method Validations
How to perform successful test method validations
Who Will Benefit:
Manufacturing Engineers
Regulatory Affairs Teams
Quality Assurance & Quality Control Teams
Operations Teams
Document Control
Speaker Profile:
Jose Mora is a Principal Consultant specializing in Manufacturing
Engineering and Quality Systems. For over 30 years he has worked
in the medical device industry specializing in manufacturing, process
development, tooling, and quality systems. Prior to working full time
as a consulting partner for Atzari Consulting, Jose served as Director
of Manufacturing Engineering at Boston Scientific and as Quality
Systems Manager at Stryker Orthopedics, where he introduced
process performance, problem solving, and quality system
methodologies.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Those who work with process optimization and validation focus on
optimizing a process and reducing variability. Those working on Test
Method Validation, on the other hand, focus on discerning between
process variation and measurement error from the test method itself.
Why should you Attend:
This webinar will help you better understand Test Method Validations
to verify the performance of a Medical Device, global reference
standards, the FDA requirements and how to perform successful TMV
to ensure your inspection of verification is effective, using detailed
real-life case studies.
Areas Covered in the Session:
When should Methods be Validated?
Qualification vs Validation
Types of Test Method Validations
How to perform successful test method validations
Who Will Benefit:
Manufacturing Engineers
Regulatory Affairs Teams
Quality Assurance & Quality Control Teams
Operations Teams
Document Control
Speaker Profile:
Jose Mora is a Principal Consultant specializing in Manufacturing
Engineering and Quality Systems. For over 30 years he has worked
in the medical device industry specializing in manufacturing, process
development, tooling, and quality systems. Prior to working full time
as a consulting partner for Atzari Consulting, Jose served as Director
of Manufacturing Engineering at Boston Scientific and as Quality
Systems Manager at Stryker Orthopedics, where he introduced
process performance, problem solving, and quality system
methodologies.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Event Categories
BUSINESS & MANAGEMENT CONFERENCES
, EDUCATION CONFERENCES
, Finance
, HEALTH AND MEDICINE CONFERENCES
, Healthcare
, Life Sciences, Biotechnology
, Technology
Keywords: Educational, pharmaceutical , technology , training , medica