Quality Risk Management tools to improve data integrity in micro QC
Speaker
Jordi Iglesias, Technology and Market Development Manager II, Charles River Laboratories
Jordi Iglesias is a product specialist with Charles River’s Microbial Solutions team, serving as a technology and market development manager for the Endosafe® (endotoxin testing) brand in Europe while providing support in Spanish-speaking regions. Previously, he worked in the pharmaceutical industry as an aseptic and microbiology lab manager at Zoetis for nearly 15 years. While there he designed product validations (bioburden, sterility and endotoxins), environmental monitoring plans, cleaning and disinfection programmes, and training for aseptic area operators; he was also part of the human performance (human error assessment) group. In addition to his role at Charles River, Jordi is a member of the European Directorate for the Quality of Medicines (EDQM) microbiology group.
Related topics
Analytical techniques, Assays, Biopharmaceuticals, Data integrity, Endotoxin, Environmental Monitoring, Gene therapy, Good Manufacturing Practice (GMP), ICH guidelines, Lab Automation, Medical Devices, Microbiology, Outsourcing, QA/QC, Regulation & Legislation, Supply Chain, Vaccines
Hi,
1) What method/tools would you advice for integration of quality risk management into industry and regulatory operations?
2) Would you advice on algorithm based system for generation of final risk assessment score or would individual discretion based on set principles/SOPs suffice? I believe algorithms are lesser prone to biases than the maul system where favoritism can corrupt the system with cover-ups taking on the center stage.
Thank you.