cGMPs

How Process Management Informatics Supports ICH Q8, Q9, Q10, Q11 and Continuous Process Verification

Pharmaceutical manufacturers are, on whole, not experiencing a lack of data. However, the current regulatory environment, quality product and good business practices require effective data management and analysis to facilitate science-based approaches.

Presented by Justin Neway, Ph.D., Chief Science Officer, Accelrys ADQM Group 
On-demand presentation: 29:03 

 

"It should be recognized that the level of knowledge gained, and not the volume of data, provides the basis for science-based submissions and their regulatory evaluation." 

By viewing this presentation you will learn:
•What is Process Management Informatics?
•Meeting current regulatory requirements utilizing process management informatics
•Effectively handling product and process development, quality risk management, continuous improvement

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