Redefining Pharmaceutical Process Validation

FDA's new process validation guidance spells out the new rules for process validation. In this webcast, industry experts discuss the guidance, what it means to manufacturers, how to apply a Six Sigma approach to validation and how to apply new principles to improve a legacy product.

For Jim Agalloco's presentation, "FDA’s Guidance for Industry Process Validation: Impact Assessment", click here.

For Bikash Chatterjee's presentation, "Building and Tailoring a Lean Six Sigma Approach for Validation Processes", click here.

For FDA/CDER's Joseph C. Famulare's presentation, "Process Validation – Key Areas Leading to 483’s", click here.

For NNE Pharmaplan's Line Lundsberg-Nielsen's presentation, "The Impact of FDA’s Proposed Process Validation Guidance on Quality by Design for Legacy Products", click here.

For additional information on our upcoming webcast series, click here.