The Webinar will focus on understanding the importance of combining statistical analyses, visual data exploration, and process knowledge in making optimal enhanced sampling decisions. Specifically, participants will learn:
Partner at SynoloStats LLC
Eight years after the FDA Guidance which introduced the Lifecycle Approach to PV the need for enhanced sampling during Stage 2 (PPQ) and Stage 3a (initial CPV/OPV) in order to understand within and between batch variability is broadly recognized in the industry. One-size-fits all enhanced sampling plans or plans based on statistical rules can be highly ineffective, often resulting in too few or too many samples being taken. Such practices can fail to reap the business and patient benefit of additional process understanding. Statistical thinking is the primary enabler of choosing optimal sampling plans, or sampling plans in the “Goldilocks Zone.” This webinar will address the role of statistical uncertainty and the implications for designing sampling plans that optimally address the goal of better process understanding throughout the process lifecycle.