Conference Description:

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: [email protected]