The seminar will be presented by Tiffany Rau, Ph.D., Senior Consultants (read her profile here) and Howard L. Levine, Ph.D., President, CEO, and Principal Consultant, BioProcess Technology Consultants (read his profile here).
When: March 8th, 9:00 – 13:30
Where: Faros – Oslo Science Park
Please send an email to: firstname.lastname@example.org to sign up for the seminar no later than March 7th at 10:00 AM.
BPTC will present an overview of current validation requirements and expectations for biopharmaceuticals with an emphasis on the key concepts that interplay in defining and implementing Quality by Design (QbD) for the manufacture of these products. Concepts discussed in the workshop will include: Roadmap for implementation of QbD, Critical Quality Attributes (CQA), Design Space, Quality Risk Assessment and Quality Risk Management (QRM), Control Strategy, Process Analytical Technology (PAT), Process Validation, Multivariate Data Analysis (MVDA), Process Monitoring and QbD Filing. The course will also include case studies on establishing and implementing a Process Design Space using QbD, application of MVDA for Root Cause Analysis for a Mammalian Cell Culture Process, and conducting a Process Risk Assessment using FMEA. At the end of the workshop, the audience will understand the concepts of process validation and QbD and the role they play in QbD implementation. Anoutline of the workshop is provided below.
NB:lunch is included
TLSC members: 3000 NOK
Non-members: 6500 NOK
Special offer for non-members: If you join TLSC as a member, you will be eligible for the members price. In addition, you will receive a 1000 NOK discount on the regular TLSC membership fee.