2019 - Medical Devices - Complying With 820.250 Statistical Methods
Date2019-02-04
Deadline2019-02-03
VenueFremont, USA - United States
KeywordsValid statistical rational; Internal Auditors; Compliance trainings
Topics/Call fo Papers
Overview:
In this webinar you will learn how to structure your statistical procedures to ensure compliance, and how to avoid these and how to fully comply with the statistical regulations.
Why should you Attend:
Two of common 483 and Warning letter items are:
Lack of valid statistical rationale
Inadequate trending of Quality data
Learn how to avoid these and how to fully comply with the statistical regulations
Areas Covered in the Session:
Important elements for each procedure
Valid statistical rational
Structuring the procedures to reduce the training burden
Deviating from procedures
Handling when there is not a procedure
Who Will Benefit:
Corporate and Division Management
Regulatory Management and Personnel
Internal Auditors
QA/QC Engineers and Management
Process Engineers and Management
Design Engineer and Management
Statisticians
Speaker Profile:
Wayne Taylor is a leading expert on the application of Statistics to the Medical Device and other FDA regulated industries. His new book Statistical Procedure for the Medical Device Industry sets the standard for applying statistics in compliance with Section §820.250, Statistical Techniques of the Code of Federal Regulations.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14-AT-gmail.com
In this webinar you will learn how to structure your statistical procedures to ensure compliance, and how to avoid these and how to fully comply with the statistical regulations.
Why should you Attend:
Two of common 483 and Warning letter items are:
Lack of valid statistical rationale
Inadequate trending of Quality data
Learn how to avoid these and how to fully comply with the statistical regulations
Areas Covered in the Session:
Important elements for each procedure
Valid statistical rational
Structuring the procedures to reduce the training burden
Deviating from procedures
Handling when there is not a procedure
Who Will Benefit:
Corporate and Division Management
Regulatory Management and Personnel
Internal Auditors
QA/QC Engineers and Management
Process Engineers and Management
Design Engineer and Management
Statisticians
Speaker Profile:
Wayne Taylor is a leading expert on the application of Statistics to the Medical Device and other FDA regulated industries. His new book Statistical Procedure for the Medical Device Industry sets the standard for applying statistics in compliance with Section §820.250, Statistical Techniques of the Code of Federal Regulations.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14-AT-gmail.com
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Last modified: 2018-12-06 15:28:15