Are you compliant with FDA requirements for process validation? This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.
With Representation From:
- Snee Associates
- PharmaTech Associates
- Compliance Team Inc
- TARIS Biomedical
- Tunnell Consult
Featuring Comprehensive Coverage On:
- FDA Process Validation and Risk Management Approaches
- Lifecycle Approach to Process Validation
- Global Technology Transfer and Process Validation
- Achieving the Business and Compliance Benefits of Quality by Design (QbD) and Continued Process Verification (CPV)
- Legacy Products – From Retrospective to Prospective Process Validation
- Validation Sampling Plans and Statistical Process Control
- Cost-effective Process Validation Lifecycle Management
- Implementing a Comprehensive Strategy for Process Validation: Stage 3, Continued Process Verification
- Establishing a Continuum of Criticality for Process Parameters and Quality Attributes Throughout the Lifecycle
- Process Control Strategy and Process Performance Qualification of a Drug/Device Combination Product
- The Drug Supply Chain Security Act-How Does it Relate to Validation?
- And Much More!
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