Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection
June 14, 2012
Location
Online Event
2600 E. Bayshore Road
Palo Alto, California 94303
USA
Description
This webinar will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business.
Why Should You Attend:
Can you show me how you manage your computer systems in compliance with 21CFR Part 11?
This presentation will describe a process which has prepared several companies to answer this question from FDA inspectors accurately, completely and to the great satisfaction of the inspectors. We will show how to inventory the site, assess the compliance risk of existing systems, implement new systems, remediate any non-compliance found, prepare SOPs and quality policies, collate the required documentation and train the staff.
Areas Covered in the seminar:
* 21CFR Part 11 Requirements.
* Regulatory Inspections of Computer Systems.
* Required Policies and Procedures.
* Training.
* Performing a Comprehensive Inventory: Team Effort.
* System Inventory Assessment - Preliminary Risk Assessment.
* Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions.
* Remediation Plans and Schedules.
* Presenting to the Inspector.
* Case Studies : Federal and State Regulatory Inspections.
Organized by
ComplianceOnline
2600 E. Bayshore Road
Palo Alto, California 94303
United States of America
More Information
Contact: Referral
Email: referral@complianceonline.com
Phone: +1-650-620-3915
Event's Website
