Quality by Design for Biopharmaceuticals - Training / Workshop von PDA Europe gGmbH

The principles and practices of Quality by Design (QbD) for biopharmaceutical, biosimilar, and other biologic manufacturing processes are here now, with regulatory authority expectation for market approval submissions to include at a minimum the quality target product profile (QTPP), identification of critical quality attributes (CQAs) and justification of critical process parameters (CPPs). The principles and practices of QbD are applicable for both in-house and contracted-out biopharmaceutical development, manufacturing and testing. Unfortunately, there is so much confusion today about what QbD is and isn’t: What is so different about QbD? Must QbD include a thorough multi-variate analysis of design space? Does QbD guarantee regulatory freedom to independently make future manufacturing process changes? Does QbD mean no future manufacturing problems? Practical suggestions to help your company apply QbD to your biopharmaceutical, biosimilar or other biologic development program will be provided by examining what has worked already for other companies. The six (6) key steps of QbD will be examined and discussed carefully. Also, this course will identify the limitations of the QbD approach. Find out more online: https://goo.gl/deGXfa