21 CFR PART 11 COMPLIANCE 2012 - Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection

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Category Auditing Systems for 21 CFR Part 11 Compliance; Federal; State Regulatory Inspections; Computer Systems Assessment

Deadline: June 14, 2012 | Date: June 14, 2012

Venue/Country: Palo Alto, U.S.A

Updated: 2012-04-05 19:53:29 (GMT+9)

Call For Papers - CFP

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.

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.