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33818 Conferences

21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel

Added by davidross759 on 2010-09-27

Conference Dates:

Start Date Start Date: 2010-11-02
Last Date Last Day: 2010-11-02

Conference Contact Info:

Contact Person Contact Person: Webinars
Email Email: webinars@globalcompliancepanel.com
Address Address: Online Training Webinar, Online, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

This webinar details the regulation and how it applies to computerized systems.

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:

* IT
* QA
* QC
* Laboratory staff
* Managers
* GMP, GCP, GLP professionals
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