The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Mar. 8 & 9, 2007
Who Should AttendThis course is designed for Quality, Data Management and IT personnel responsible for Clinical Data Systems implementation, operation and compliance. The course is of special value to personnel seeking experience with the quality issues associated with regulated computer systems. Learning Objectives The course will provide the tools needed to prepare for a Clinical Data System inspection and to assess risk areas that need prioritization. Attendees will learn how to review the system for regulatory vulnerabilities and to develop an action plan intended to close those gaps. Course Description This course focuses on preparation for FDA systems inspections whether establishing a new program or seeking improvements in an ongoing quality initiative. The course provides practical information for improving presentation and substance of Clinical Data Systems documentation in anticipation of a FDA Inspection. In addition, the course will address critical issues and potential observations resulting from a Clinical Data Systems audit. The attendee will be able to develop action plans based on course material to improve the company's compliance position for an inspection. The executed plans will also strengthen evidence that the Clinical Data System performs to business and quality expectations. Topics include the following: Inspection Fundamentals; Computer Validation and Part 11 Inspection Concerns; Assessing Standard Operating Procedures; Assessing System Documentation; Preparing for the Inspection and Maintaining Compliance. ________________________________________ COURSE AGENDA DAY ONE Overview • Inspection Fundamentals
• Revisiting Quality Procedures
• Prepping the System
• Preparing for the Inspection
• Keeping Compliant Inspection Fundamentals • Principles of Inspections
Responsibilities
General Inspection vs. Targeted Inspection
Checklist • Computer System Validation Issues
CSV Deliverables
Functional vs. User Acceptance Testing - What's the difference?
Traceability Requirements
Infrastructure Requirements
Data Management Concerns • 21 CFR Part 11 Issues
Intent to Use ERES
Inventory
Assessment and Remediation Plans
State of the System(s) Revisiting Quality Procedures • Expected System Procedures and Processes
• Expected Data Quality Procedures
• Expected Operations Management Procedures
• Addressing the Gaps DAY TWO Revisiting System Documentation • Performing a Gap Analysis -What is missing?
• Filling in the Evidence Gap - Selective Testing Approaches
• Retrospective vs. Prospective Activities
• Example - Clintrial/Oracle Clinical Preparing for the Inspection • Responsibilities
• Hard Questions - A matter of readiness!
• Mock Audits/Internal System Audits Keeping Compliant • Responsibilities
• Moving to a Proactive Approach - Improving Your Systems Quality program
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