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

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.

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

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

Others Details

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