Quality by Design (Q-b-D) for Biopharmaceuticals
WPI Biomanufacturing Education and Training Center
Application of Quality by Design (Q-b-D) methodology for product commercialization is increasingly becoming the standard business practice at Pharma and Biotech companies. It is also much sought after by US and EU regulators as an approach presented in regulatory dossier to demonstrate that product will be safe and effective consistently over its lifecycle. While the concept of Quality by Design is universal and commonplace in many sectors, its application in Biotech industry for product commercialization is relatively new and “purpose-built” to suit the nuances of the products and processes.
- Program Schedule: June 11-13, 2019
- Location: WPI Boston Seaport Office – 303 Congress St., Boston, MA
- Time: 8:30am – 4:00pm
- Price: $2,925
- CEU: 2.1
Who Should Attend
This 3 day course containing workshops, case studies and Q&A sessions is intended for scientists and engineers who are new to Quality-by-Design and/or need an update in their knowledge of the subject. The course is designed and delivered by a leading industry expert who is engaged on a daily basis with all aspects of Q-b-D, from late phase process design, characterization and Tech Transfer to biomanufacturing, validation and regulatory aspects.