Search results for " training"
Article
DoE Provides Benefits, but Preparation Is Necessary
Consequently, reaping the benefits requires a significant commitment to DoE, including the training of researchers in study design and data-processing techniques.
The benefits of DoE
One of th…
Article
Challenges in Analytical Method Development and Validation
Often, a lack of clarity in the validation protocol, poor preparation and planning, and/or insufficient analyst training can result in unplanned deviations.
A validation failure results from failin…
Article
The Importance of Partnering for Bioanalytical Studies
These involve a lot of experimentation, data curation and storage, quality review, personnel training, generation of SOPs, etc.—all related documentation should be available for review by FDA, along w…
Article
Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Such procedures may include aseptic training, purchasing of suitable raw materials, raw material supply-chain management, and cleaning and sanitization, for example.
Biosafety should b…
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
Article
Improving Upstream Predictability
Training needs
Change within the biopharmaceutical space has brought with it demands for new skillsets and training. Where, in the past, companies sought biochemists with basic cell culture …
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
The Metrics of Quality Culture
…al deviation (real or due to insufficient analysis) was determined to be insufficient or ineffectual training. The third proposed metric is intended to measure a firm’s process capabilities through a…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
The blame frequently falls on lack of effective training. The root cause, however, may be documents that are too complex. Fueling the complexity, multiple changes (e.g., addition of steps, changes to …