GEN - Genetic Engineering and Biotechnology News15 天
AI Could Revolutionize Biopharma Process Validation
While AI adoption in GMP settings is still evolving, regulatory agencies emphasize explainability and validation of AI models.
Stockhead on MSN1 个月
Imricor hits key milestone in FDA approval process for ablation catheter devices
process validation, part and device traceability, along with the applicable quality management systems. Imricor is executing ...
FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance
The new entry to FDA’s database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods—Understanding and use of product bioburden data. Three of AAMI’s most notable ...