Which data and systems are subject to Part 11

Published 1 month ago by COMPLIANCE4ALL on EDUCATION 80 Views
Overview:
This webinar details the regulation and how it applies to computerized

systems. Learn exactly what is needed to be compliant for all three

primary areas: SOPs for the IT infrastructure, industry standards for

software product features, and the 10-step risk-based validation

approach.

Areas Covered in the Session:
Which data and systems are subject to Part 11
What Part 11 means to you, not just what it says in the regulation
Avoid 483 and Warning Letters
Explore the three primary areas of Part 11 compliance: SOPs, software

product features, and validation documentation
Ensure data integrity, security, and protect intellectual property

Who Will Benefit:
IT
QA
QC
Laboratory Staff
Managers
GMP, GCP, GLP Professionals

Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years in

management of development of medical devices (5 patents). He has

been consulting in the US and internationally in the areas of design

control, risk analysis and software validation for the past 8 years.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]