Which data and systems are subject to 21 CFR Part 11

Added by Compliance4all on 2018-04-19

Conference Dates:

Start Date Start Date: 2018-06-08

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email: [email protected]
Address Address: 161 Mission Falls Lane, Suite 216,, Fremont, CA, 94539, United States
Phone Tel: 18004479407
Phone Fax: 302-288-6884

Conference Description:

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:
Ensure data integrity, security, and protect intellectual property
Understand the current computer system industry standards for security, data transfer, and audit trails
Electronic signatures, digital pens, and biometric signatures
SOPs required for the IT infrastructure
Product features to look for when purchasing COTS software

Who Will Benefit:
Quality Assurance
Quality Control
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.

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

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