The Life Sciences industry is tasked to keep up with demand while maintaining quality and meeting regulatory requirements. Each batch must meet quality and safety standards.
According to FDA Drugs Recall Statistics,
- 89.9% Class 1& 2 recalls are associated with manufacturing or product quality issues
- 1279 avg. FDA recalls/year are mostly associated with manufacturing or product quality
- 80% of batch failures are due to contamination, operator error, equipment failure, failure to meet specs.
Does your Life Sciences process also struggle with:
- Keeping track of all the variables involved in complex formulations?
- Getting feedback on manufacturing efficiency from siloed systems?
- Tracking and reporting on quality assurance and regulatory affairs?
Join this webinar to learn how batch performance analytics can help with challenges around process development, manufacturing operations and QA/regulatory affairs. Batch performance analytics supports with consistently producing batches with set specifications, quickly identifying contributing factors in production variability and helping to improve regulatory compliance by automating data collection, analysis, and reporting of continued process verification.
Our speaker, Ankit Jain , Regional Lifesciences Industry Consultant, Asia Pacific, will cover how Batch Performance Analytics helps you
- Unlock the Golden Batch
- Improve compliance through automated continuous process verification (CPV)
- Streamline the manufacturing life cycle
