Regulatory requirements, lot release, in-process testing, risk mitigation, live mycoplasma requirements, sensitivity, specificity, validation considerations, 28-day vs same day, compendial vs. rapid microbial – What are your mycoplasma questions? Our panel of experts will be live to answer all your questions regarding implementation and validation of a rapid mycoplasma system.
In this live session, you will get answers to your questions.
Potential topics that may arise:
• Key points to consider before validating a qPCR Mycoplasma method
• Different approaches to address regulatory comparability requirements of qPCR to compendial method
• Validation guidance for qPCR mycoplasma method
Who should attend:
• QC/QA Managers
• Process Analytics Managers
• Process Development Managers
• Regulatory Affairs Managers