This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Anyone relying on the particle size results from DLS or liquid particle counters should consider and address how the data will be used and how to assure the quality of the final results. This ...

Computational models and simulations have had an important role in engineering analysis since as far back as the 1960s. It is widely recognized that the use of modeling and simulation tools can make ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...