GlobalCompliancePanel, Online Training
2012-04-12
Overview: This course will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company and the industry, and provide guidance on how your company can ensure that they have a successful inspection.
Interactive course to cover all areas of 21 CFR 11 and how to include 21 CFR 11 requirements in computer systems validation. Will include exercises where the attendees will build all the deliverables for a computer system using the 21 CFR 11 principles and requirements. Finally, a fun ‘Jeopardy’ quiz will be used to test the participants’ knowledge Agenda: INTRODUCTION TO 21 CFR 11 - History of 21 CFR 11
- Current Status of 21 CFR 11
- 21 CFR 11 Overview
- 21 CFR 11.10 (a)-(k)
- 21 CFR 11.30
- 21 CFR 11.50
- 21 CFR 11.70
- 21 CFR 11.100
- 21 CFR 11.200
- 21 CFR 11.300
- The FDA's Requirements for 21 CFR 11
- FDA's Add-On Inspections for 21 CFR 11
21 CFR 11.10 (A) COMPUTER SYSTEMS VALIDATION DELIVERABLES - Risk Assessment
- Vendor Audit
- Validation Plan
- Requirements Specification
- Design Specification
21 CFR 11.10 (A) COMPUTER SYSTEMS VALIDATION DELIVERABLES - Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Traceability Matrix
- Validation Summary Report
- Validation Registry
- SOPs
- 21 CFR 11 Audit
21 CFR 11.10 (A) COMPUTER SYSTEMS VALIDATION DELIVERABLES EXERCISE · Create ALL Deliverables for a Laboratory Information Management System (LIMS) · Jeopardy - Test Your Knowledge Who will benefit: • Everybody using computers in FDA or regulated environments
• IT manager and staff
• QA managers and personnel
• Regulatory affairs
• Training departments
• Consultants
• Validation specialists
• Project Managers
• Vendors of COTS (Commercial Off The Shelf) systems in regulated industries
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