Presented by: Philip Jarvis, Director C&Q and Digital Validation Strategy, VEQTOR How digital validation tools are enabling validation 4.0Risk 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 defining […]
Presented by: Dr. José C. Menezes, CSO, ValGenesisJoin 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, and […]
Created by: Fred Ohsiek, Cleaning Validation ExpertGrouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime. Though regulatory [1] [2] and industry guidelines [3] support the practice and provide guidance, there is a clear requirement for scientific justification.Common industry practice is to either avoid grouping because of perceived risk […]
Created by: Fred Ohsiek, Cleaning Validation ExpertThis article not only applies to high potent (HP) active pharmaceutical ingredient (API) manufacturing, but it also includes pharmaceutical manufacturing products with HP APIs; therefore, the term “HPAPI manufacturing” and “HPAPI product” applies to both types of production.It is important that the requirements for the finished manufacturing companies are […]
Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]
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