Search results for "Training" in Articles / App Notes
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
Article
Early Communication with Regulators is Essential for SMEs
The companies are being offered free or heavily discounted regulatory and administrative assistance, training sessions, evaluation, and above all, scientific advice that can raise the chances of a new…
Article
Trends in Downstream Bioprocessing
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
Article
Operational Excellence: More Than Just Process Improvement
The ultimate goal was not simply to make the processes compliant, but to create sustainable improvement by training all stakeholders, not just a targeted few; increasing collaboration and partnership …
Article
Elucidating Biosimilars Characterization
BioPharm International spoke with Jonathan Bones, principal investigator at Ireland’s National Institute for Bioprocessing Research and Training (NIBRT); Reg Shaw, PhD, CEO of NIBRT (collectively refe…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
Essentials in Quality Risk Management
An implementation plan with tools, training, and standard operating procedures are needed to build a low-risk development and manufacturing platform. Management involvement is needed to trigger risk-a…
Article
QbD and PAT in Upstream and Downstream Processing
Couple that with strong operator training and having real-time process adjustments is already inherent in a process without PAT. Generating dynamic and static control charts on a per-run basis of the …
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
PDA's Technical Report for Biotech Cleaning Validation
Training and retraining for manual cleaning processes are also significant because they are the primary mechanisms for obtaining consistency in manual cleaning processes.
For biotech and nonbiotec…