Internal 21CFR Part 11 Compliance Auditing of Computer Systems
Overview:
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:
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. 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