Overview:

This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.

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:

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. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management.

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