Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel

Website https://www.globalcompliancepanel.com/control/w_product/~product_id=600455?channel=mailer&camp=webin | Edit Freely

Category Health Care, Medical Device, Compliance Training

Deadline: May 12, 2011 | Date: May 12, 2011

Venue/Country: Wilmington, U.S.A

Updated: 2011-04-07 15:25:04 (GMT+9)

Call For Papers - CFP

This presentation will describe a proven process for preparing a site for inspection of systems. Case studies will be used to illustrate how this process has successfully prepared several pharmaceutical companies to answer this question accurately, completely and to the great satisfaction of the inspectors. We will review and illustrate audit plans, system inventory, system audits, CAPA and remediation programs.

Why should you attend:

"Show me how you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or state regulatory inspector can send shivers down your spine. Are you ready for an internal QA or FDA inspection at your site?

Areas Covered in the Session:

* 21CFR Part 11 Compliance

* Review of the regulations

* Regulatory requirements

* Site Inventory

* Compliance Assessment

* Risk Assessment

Who Will Benefit: The employees who will benefit include:

* End-users responsible for applications that need to be validated

* QA managers and personnel

* Information Technology managers and personnel

* Validation specialists

* Consultants

* Quality system auditors

* Will provide forms and templates for the processes

Price List:

Live : $245.00

Corporate live : $995.00

Recorded : $295.00