Search results for " skills" in Articles / App Notes
Article
Biopharma Advances Demand Specialized Expertise
Maintaining a focus during early development on eventual commercial manufacturing requirements, while balancing limited development resources requires a broad base of coordinated, organizational skill…
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
Article
Drug Discovery and Development in India
Apr 01, 2015
By Jane Wan
BioPharm International
Volume 28, Issue 4
Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s …
Article
Finding Opportunities in Brazil
Feb 06, 2015
By Hellen Berger
BioPharm International
Volume 28, Issue 2
Brazil’s turbulent presidential election in October 2014 shed some light on the country’s political landscape …
Article
DoE Provides Benefits, but Preparation Is Necessary
It is all of the extra training to develop my applied statistics skills, including six-sigma training and seminars, that helps me on the job,” he states.
About the Author
Cynthia A. Challener …
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Of these three options the reliability approach (Option 3) is the most robust, but requires sophisticated statistical skills. This option may be reserved for only very high risk CPPs.
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Article
Operational Excellence: More Than Just Process Improvement
Deviation reports were made the responsibility of a single investigator with specific analytical and investigation reporting skills. The reports were then designed to connect the event and its root ca…
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Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanuf…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Additionally, agency reviewers have also had the opportunity to maintain their scientific and medical skills by participating in clinical work, research, or teaching opportunities at UMD and GU CERSI.…