GEN - Genetic Engineering and Biotechnology News8 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 ...
How to Write Effective Standard Operating Procedures (SOPs) and Other Process Documents for ...
The "How to Write Effective Standard Operating Procedures (SOPs) and Other Process Documents" training has been added to ResearchAndMarkets.com's offering. Standard Operating Procedures (SOPs) are ...
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 ...
Yahoo Finance28 天
3hr Virtual Seminar: Validation, Verification and Transfer of Analytical Methods ...
This 3-Hr webinar on "Validation and Verification of Analytical Methods" by Dr. Huber will discuss the recent changes in guidance from regulatory agencies (FDA/EMA, USP and ICH) on method ...
Stockhead on MSN24 天
Imricor hits key milestone in FDA approval process for ablation catheter devices
The second module for Imricor’s premarket approval products has been submitted to the US FDA Module two comprises ...