Search results for "Training" in Articles / App Notes
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
Despite these technology advances, a successful data integrity program will be contingent upon human factors: employee training, implementation, and oversight.
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Article
Managing Risk in Raw Material Sourcing
Avantor has installed MasterControl quality management system (QMS) software across its cGMP manufacturing sites to manage documents, quality training, corrective actions and preventive actions, and o…
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Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
Article
Design and Qualification of Single-Use Systems
Manufacturability should also include operator training and in-process and final product testing (as needed) for quality factors such as integrity (i.e., retention properties of filters, leak absence …
Article
Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
By Siegfried Schmitt
Q: We are a contract manufacturing organization (CMO), sp…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
CMOs Continue to Improve Overall Biomanufacturing Performance
These range from better analytical testing and product release services to better operations staff training, optimized media and improved existing quality management systems. Better process developmen…
Article
Fluid Handling in Biopharma Facilities
I think the cost of SUS must justify the reduction of contamination risk and reduction of facility support/utility requirements, not to mention the shortened start-up time that also includes the train…
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Cleaning of Dedicated Equipment: Why Validation is Needed
It aims at harmonizing inspection procedures globally by developing common GMP standards, training inspectors, and facilitating exchange of information and mutual confidence between regulators.
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Iss…