SES112 - Quality Risk Management Application to Pre-PV Decision Making, Eqpt. Qualification and Cleaning Processes

This session will highlight the importance of commissioning and qualification throughout the biopharmaceutical facility with a focus on manufacturing operations.
First, the audience will learn about the importance of harmonized decision-making framework and risk-based evaluation of the need for manufacturing a pre-PV (process validation) demonstration batch. Included are decision flow chart, previously manufactured batch assessment tools and case study application examples. Next, the speakers will provide an overview on of the current state of the industry in regard to adoption rate of Quality Risk Management (QRM) Based Integrated C&Q, C&Q best practices, benchmarking and key performance indicators.
To conclude this session, the last presentation of the session will discuss relevant topics necessary to develop a comprehensive assessment to characterize cleaning program practices, typical observations from assessments, and sustainability opportunities identified in reduced water usage, optimized chemistries, cleaning cycle duration reduction, potential energy reductions, and developmental studies to support identified solutions.
Each presentation will conclude with a brief Q&A and discussion where everybody is encouraged to ask questions and discuss with the speakers.

15:30 -16:05: Risk Based Decision Process for Pre-PV Demo Batch by Joanne R. Barrick
16:05 - 16:30: Adoption of Integrated C&Q - Benchmarking & Survey Results by Nathan W. Temple
16:30 - 17:00: Sustainability Through Cleaning Program Standardization by Keith Bader and Andy Brewer