21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar By GlobalCompliancePanel
Venue: Online Training Webinar
|Event Date/Time: Feb 24, 2011||End Date/Time: Feb 24, 2011|
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. 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.
* 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.
* Reduce validation resources by using easy to understand fill-in-the-blank validation documents.
Who Will Benefit:
* Laboratory staff
* GMP, GCP, GLP professionals