21 CFR Part 11: Complying with Part 11 Regulation - Understanding the Predicate Rule - Webinar By GlobalCompliancePanel November 6, 2012

Overview: Overview of the Part 11 regulation; Description of HOW TO ensure compliance with Part 11; Internal and External audits for compliance with Part 11; Key terms and definitions; Example of solid compliance; Examples of non-compliance; Examples of Warning Letters; Tools for compliance; Further readings, trainings and opportunities related to Part 11.

Why should you attend :More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more and more of the computer technologies. Part 11 is a regulation that regulates the technology when it comes to electronic signatures and electronic records.

In a time of global economy when and where time is of essence, having an ability to access records from any location around the world is more critical than ever, and for the same reason, electronic records will be more needed and desired in each organization. In addition, approval of documents and records in a timely fashion is absolutely needed at all times, and being able to do just that via an electronic media is understood. For both, electronic signatures and electronic records, the organization shall comply with the Part 11 regulation.

Areas Covered in the Session
Overview of the Part 11 regulation
Description of HOW TO ensure compliance with Part 11
Internal and External audits for compliance with Part 11
Key terms and definitions
Example of solid compliance
Examples of non-compliance
Examples of Warning Letters
Tools for compliance
Further readings
trainings and opportunities related to Part 11

Who Will Benefit:
Quality Managers
Quality Engineers
Small Business Owners
Internal and External Auditors
Management Reps
FDA Inspectors
Consultants

Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

[email protected]
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/UIgrvw