Search results for " event" in Articles / App Notes
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
A “special cause” is an event or trend in the data set that is statistically unlikely to occur if the process is maintaining a level of control. There are several quality and statistical references (1…
Article
FDA Seeks Metrics to Define Drug Quality
Most obvious are reports of company recalls, poor inspection outcomes, and adverse events that are visible to FDA and can indicate broader deficiencies in manufacturing process and control strategy.
…
Article
Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
During the meeting the outbreak of thromboembolic events (TEE’s), causing IVIG product withdrawal some years ago, was still discussed. However, compared to the previous meeting in 2010 the perception …
Article
Essentials in Quality Risk Management
The first definition is traditional and takes into account potential failures and adverse events. The second takes into account influence of factors relative to CQAs and how well we understand or know…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
…to agency reviewers?
FDA: Agency reviewers have had the opportunity to participate in training events sponsored by both UMD and GU CERSIs. These events have provided continuing medical educatio…
Article
Sterilization Trends for Single-Use Consumables
“As EtO and gamma irradiation, the principal methods used today, have a limited supply capacity, concerns persist that regulation changes, newsworthy events, and supply-chain constraints could easily …
Article
Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
Attend this virtual event on-demand to learn more about how this filter can help you achieve the gains you need in your process. Topics covered include:
• The changing biopharma landscape and the …
Article
Recap: Chromatography + filtration virtual summit 2024
Don’t worry – here are the highlights and session recordings from the event on optimizing purification and filtration for mAbs, antibody variants, recombinant proteins, and gene therapy.
See highli…
Article
Fast Trak™ training and education courses for 2024
Dates for 2024 events are live!
Find out more
Article
Detailed agenda for Chromatography + filtration virtual summit
Registration is free of charge - see you there!
Register for the event