Search results for "Training"
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…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…