Process Risk Management Strategies – Reduce Risk and COGS While Improving Yield and Compliance
November 15, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:1-416-915-4458
A critical source of risk to patients using pharmaceuticals to improve their health is inadequate design and control of the processes that manufactured the drugs. R&D, Manufacturing, Quality Assurance, Quality Control and Regulatory Affairs play a critical role in reducing risk associated with poorly operating processes. The ICH guidance documents Q8, Q9 and Q10 has heightened awareness in the pharmaceutical and biotech industries of the need to reduce process risk. This trend is also being promoted by the FDA as an approach to process improvement with the benefit of enhanced regulatory flexibility. But the questions remain: What does it mean to reduce risk, to manage risk, and how do you do it? Fortunately we have a lot of experience on which to draw.