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Welcome to seminar in: Quality by Design (QbD) and Validation for Biopharmaceuticals by BPTC!

March 8 @ 09:00 - 13:30

The Life Science Cluster is happy to invite you to a half day seminar about Quality by Design (QbD) and Validation for Biopharmaceuticals by BPTC!

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: iselin@tlsc.no to sign up for the seminar no later than March 7th at 10:00 AM.   

Seminar Description
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 

Read about the detailed seminar outline here (PDF) 

Check out the BPTC Brochure here (PDF)

Ticket prices:
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.

Details

Date:
March 8
Time:
09:00 - 13:30
Event Categories:
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Venue

Faros – Oslo Science Park
Gaustadalléen 21, 0349 Oslo
Oslo, Norway