Presented by: Dave DeLuca, Lakshmi Chitrapu, and Ken Shitamoto This webinar covers the following topics: Recognizing the interconnectedness of GxP and non-GxP regulations is key to developing a comprehensive compliance strategy. Integration allows organizations to streamline processes, reduce redundancies, and ensure consistency across regulatory requirements. Achieving synergy between GxP and non-GxP regulations enhances operational efficiency, […]

Presented by: Philip Jarvis, Director C&Q and Digital Validation Strategy, VEQTOR How digital validation tools are enabling validation 4.0 Risk based data integrity processes (importance of data mapping and criticality of data) Building in Data integrity by design into digital validation systems Data integrity guidance watchouts – Bring paper into the digital world compliantly and […]

Presented by: Dr. José C. Menezes, CSO, ValGenesis Join us for a webinar where we’ll delve into the practical application of ICH Q12 principles for biopharma operations. Biotech processes prior to QbD use control strategies that lack understanding of criticality and definition of CPPs or CQAs. Discover how to define these parameters from manufacturing history, […]