Quality by Design Landscaping
UPCOMING PROGRAM DATES: June 13-15, 2017
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.
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.
PREREQUISITE:
A 2-hour online lecture must be viewed anytime prior to the start of the program.
PROGRAM LOGISTICS:
- Program Schedule: June 13-15, 2017
- Location: Biomanufacturing Education & Training Center (BETC) WPI Gateway Park 2, 50 Prescott Street (2nd floor), Worcester MA
- Price: $2, 925
- CEU: 2.3
WHAT YOU WILL LEARN:
This course will take the students through the journey of using a combination of classroom presentations and case studies such that they will be “ready” to participate in Q-b-D related activities related to a Biotech product.
- Introduction to Q-b-D principles- A science- and risk-based approach
- Product understanding – Critical Quality Attributes (CQAs) – patient safety and needs
- Process understanding
- Development of Process and Analytical Control Strategy
- Statistical Methods and data analysis
- Quality Risk Management (QRM)
- Design of Experiments (DOE)
- Process Optimization & Response Surface Methodology– Ranges, Design Space,
- Root causes analysis – FMEA, risk ranking and apply FMEA to Control Strategy selection
- Technology Transfer to manufacturing and Continuous Process Verification Strategy
- CASE Studies
Naveen Pathak is head of QbD Systems at Shire. He currently leads a group that owns the maintenance and continuous improvement of QbD and Process Validation related systems. Prior to joining Shire, Naveen has worked at leading biotech and pharmaceutical companies, including Genzyme, Amgen, DSM, and Novartis in Process Development and Manufacturing Science functions. Naveen is a seasoned biopharmaceutical industry professional with 20+ years of experience in process development and technical support spanning non-clinical, clinical, and commercial manufacturing. He has a Masters in Chemical Engineering from University of Oklahoma and Graduate certificate in Quality and Regulatory Affairs from Temple University. Naveen is also actively engaged in teaching QbD related courses at Graduate Schools in US.
He is recognized as a flexible, creative, risk- based decision maker offering a unique combination of technical and people leadership, excellent communication, and understanding of regulatory and compliance landscape.
