Getting your know to flow
Getting your know to flow
INTRODUCTION Two mid-sized biotech companies with multiple commercial products, Band-Aid Bio and Forward Biotech, have similar issues with their master data knowledge management. Each takes a different approach to addressing these issues. Case 1 Some licensed parameters require calculation to…
Per FDA Guidance for Industry, Process Validation, process validation consists of 3 stages: Process Design, Process Qualification, and Continued Process Verification. The third stage is defined as “Ongoing assurance is gained during routine production that the process remains in a…
It’s always nice when two personal interests intersect. Obviously, I’m passionate about knowledge management in the biotech industry. Over the past year or so, I have become increasingly interested in human-focused business models. In this pursuit, I have been reading…
Knowledge Management in the biotechnology industry is an important buzz word right now. It is recommended by regulatory agencies (FDA, ICH) and is the focus of industry collaboration groups (BioPhorum). The BioPhorum BioManufacturing Technology Roadmap has a Knowledge Management path.…