Compliance with 21 CFR Part 11 (Data Integrity)

Overview:

It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR).

Areas Covered in the Session:

What 21 CFR Part 11 means today

Purpose of Part 11

What does Part 11 mean?

SOPs

System features

Infrastructure qualification

Validation

Who Will Benefit:

GMP, GCP, GLP, Regulatory Professionals

QA/QC

IT

Auditors

Managers and Directors

Software Vendors, Hosting Providers

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

Speaker Profile:

David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.