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.
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. The course is taught by Naveen Pathak, head of QbD Systems at Shire, where he currently leads a group that owns the maintenance and continuous improvement of QbD and Process Validation related systems. He has over 20 years experience in the industry.
- Program Schedule: April 23-25, 2018
- Registration Deadline: Two Weeks Prior to Program
- Time: 8:30am – 4:00pm
- CEU: 2.3
- Visit the link below for more information and cost of the course.