Process Validation for the 21st Century

Venue: Hilton Philadelphia Airport

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Mar 30, 2010 End Date/Time: Mar 31, 2010
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Purpose, Benefits and Objectives of Process Validation
New Draft Guidance on Process Validation Global Regulatory Requirements for Process Validation
ICH Q8, Q9 and Q10, and ISO requirements for Process Validation
Validation as Part of the Quality Management System
Process Validation Life-Cycle
Planning and Resource Requirements
Differentiating between equipment, process, and product
Compliance Requirements for IQ, OQ, PQ
Process Monitoring, Control and Documentation
Validation techniques: Process Characterization and Process Flowcharts
Ensuring Completion of Pre-Validation Activities
Revalidation and Post-Validation Activities
Failure Mode and Effects Analysis (FMEA)
Integrating Quality Risk Management to Process Validation
Developing & Implementing Validation Protocols
Establishing records documentation requirements
Preparing a Validation Summary Report
Designing and Utilizing the PV Master Plan
Preparing a Validation Assessment Checklist
Handling validation deviations