The goal of the revised quality metrics guidance is the collection of quality metrics data from life science companies to foster the FDA’s aim for risk-based inspection planning.
- How does the FDA intend to use the quality metrics data?
- What data are the FDA proposing is reported?
Attend this webinar to learn what steps you need to take to prepare for the FDA Quality Metrics Program. By the end, you’ll:
- Understand the FDA’s Quality Metrics Vision
- CDER and CBER perspectives
- Voluntary phase
- Compliance versus quality
- Learn How to Develop Enterprise-Wide Quality Metrics for Product Lifecycle
- Keep it cost-effective
- Validate your models and systems
- Balance lagging versus forward quality indicators
- Determine which metrics matter: Key Performance Indicators
- Link to Lifecycle Process Validation
- Begin with QbD
- Install continuous verification scheme
- Trend critical quality attributes and process parameters
- Establish alert and action limits
- Consider Alternative Metrics
- Measure quality culture
- Cultivate quality through continuous improvement
- Stay ahead of the curve! Register today to understand the FDA’s vision for Quality Metrics and elevate and expand your existing programs with an array of data analysis solutions.
May 30, 2017
4pm (BST) / 11am (DST)