Search results for "competence" in Articles / App Notes
Article
Using Quality by Design to Develop Robust Chromatographic Methods
ISO, ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories (Geneva, 2010).
11. M. Feinberg, et al., Anal. Bioanal. Chem. 380 (3) 502-514 (2004).
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Article
A Q&A With Phil Lester, co-organizer of the HTPD Conference
The 3rd HTPD Conference will take place this October, in Siena, Italy. Process Development Forum spoke with Phil Lester, one of the principal organizers of the conference.
PDF: This is the third…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…
Article
Trends in BioPharma Approvals in 2013
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…
Article
Best Practices in Adopting Single-Use Systems
Vendors should demonstrate competence in their clients’ bioprocessing niche, and be eager to point out how changes in equipment or operations will improve the process. Suppliers who do not provide thi…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
Article
The Future of Biopharma
What the industry's future holds and what needs to be done to get there.
The biopharmaceutical industry continues to evolve with expectations of a positive future. Much of this anticipation …