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Ref : 25449
Event :Statistical Concepts of Process Validation - 2017

Date :Wednesday July 05th, 2017

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

Overview:
Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation.

Why should you Attend:
If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material. This presentation provides the background you need on the statistical approach to process validation.

Areas Covered in the Session:
Understand the QSR requirements for process validation
Explain the FDA's approach as documented in Warning Letters
Understand the ISO 13485:2016 requirements for process validation
State the statistical model that links process input and process output
Link sampling verification to the process model

Who Will Benefit:
Quality Engineers
Production Managers
Production Supervisors
Manufacturing Engineers
Production Engineers
Design Engineers
Process Owners

Speaker Profile:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Full Details & Registration Link:

http://www.compliance4all.com/control/w_product/~product_id=501365LIVE?channel=doctorama_Jul_2017_SEO

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Statistical Concepts of Process Validation - 2017 Pharmacy - Public Health - Management
statistical concepts of process validation, medical device webinars, auditing, statistical analysis, statistical concepts and methods, trainings for quality managers, statistical concepts for data analysis, statistical concepts and tools
Professionals, Manufacturing Engineers Production Engineers Design Engineers Process Owners
100 1 --
English

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