Simplifying CPV And CPI, Accelerate Your BioPharm Product's Time To Market

By: Alberto Pascual, Director Data Science and Analytics and Mallory Turner, Sr. Manufacturing Intelligence Specialist, IDBS

Establishing a plan to collect and analyze end-to-end production and process data to ensure product outputs are within predetermined quality limits is essential. Utilizing these insights to understand root cause and provide direction on actionable Continuous Process Improvement is equally important and key to prevent failures from occurring.

Join IDBS's Mallory Turner and Alberto Pascual as they discuss best practices on meeting CPV and CPI requirements using purpose-built software that collects and transforms critical data quickly and efficiently for product lifecycle validation. In this webinar our experts cover:

• FDA CPV expectations overview
• Capturing all critical quality and process data (CPPs, CQAs, etc.) on a batch-by-batch basis
• Managing changes to target control limits and process specifications with automatic contextualization of this data
• Seamlessly generating required outputs for CPV including control charts for trending and process capability
• Automating raw material genealogy to quickly uncover the source of variations
• Establishing a secure collaboration platform to ensure effective data management across the Sponsor/CMO networks