Search results for " training"
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Best Practices for Data Integrity
If you don’t have auto-saving, then you’d better focus your efforts on training.
BioPharm: How can manipulation of electronic records be detected and prevented?
Nelson (Data…
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The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
By Jennifer Markarian
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Being Thorough When Transferring Technology
This makes clear and good procedures, and training and communications, vital to any tech transfer. In judging the success of transfers, having historical data compiled from the process using a continu…
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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.
Read more Q&As here
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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 …
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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 …
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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…
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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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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…