Process Validation for Biopharmaceuticals
Event Information
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Event Overview
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IBC's Process Validation for Biopharmaceuticals brings together process validation industry leading scientists, executives and quality assurance/regulatory experts and provides two full days of unique presentations, interactive panel discussions, conference track hopping and unprecedented networking opportunities. Case studies will offer real world examples of process validation activities implemented by industry leaders and help attendees analyze the latest industry trends including the influx in risk assessment and reduction.
2009 Conference Topics Include:
Quality by Design and Design Space
- Practical and Tangible Examples of Planned QBD Implementation
- Tactical and Relevant Approaches from small molecule QBD Implementation Applicable to Biopharmaceuticals
- Case Study: PAT in the Real World
- Unique or New Perspectives on the Harmonization of Design Space
Data, Statistics and Critical Parameters
- DOE Experiments Focusing on Crude Data
- Case Study: Design of Experiments in the Real World
- Assessing Process Components and System Components
- Multi-Component Interactions and Statistical Analysis
- Best Statistical Methods for Effective Process Validation
Niche Novel Validation Approaches
- Validating Novel or New Technologies
- Case Study: Modular Validation
- Case Study: Platform Technology
- New Thoughts on Connecting Process Characterization with Process Validation
New and Emerging Concerns
- Impact of US Approval of Follow-On Biologics
- Validating Disposables
- Submitting Accurate, Clear and Concise License Changes
- Inspection Interaction with CBER
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