PharmiWeb.com - Global Pharma News & Resources
04-Feb-2019 - 04-Feb-2019

Medical Devices - Complying With 820.250 Statistical Methods

  • Location:
    • Online

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 ยง820.250, 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@gmail.com