Search results for " training"
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.
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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…
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Biomanufacturing Outsourcing Globalization Continues
opened its Life Sciences Centre of Excellence in Shanghai, which offers biopharma process solutions (CMO work), technical, and validation support as well as training (5).
Beyond China and India, L…
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Modular Manufacturing Platforms for Biologics
Some of the oft-mentioned challenges associated with modular models deal with technical construction and the workforce planning and training required to get a facility fully operational. On-site const…
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Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Technologies and Practices Must Evolve to Meet Demand
Barriers to implementation remain; almost half of the respondents cited a lack of knowledge or training; 39% noted a lack of clarity on regulatory guidance; more than 25% noted a lack of management bu…
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Optimizing Resin Performance with Disposable Chromatography Solutions
Although the initial uptake of single-use chromatography solutions has been relatively slow, an increased need for higher-capacity resins and the demand for smaller batches has made disposable chrom…
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New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Nov 1, 2014
By: Jill Wechsler
BioPharm International
Volume 11, Issue …
Article
Setting Standards for Biotech Therapeutics in India
The government, through agencies such as the Department of Biotechnology, actively funds events that allow for training and sharing of best practices and lessons learned. Such activities are essential…