Quality by Design & Process Analytical TechnologiesAdd to calendar
Registration ends Monday November 15
Tuesday, November 30, 2021 - Thursday, December 2, 2021
Location: Stack Family Center for Biopharmaceutical Education and Training
Why Attend This Course:
- Application of Quality by Design (QbD) methodology for product commercialization and incorporation of Process Analytical Technology (PAT) is increasingly becoming the standard business practice at biopharmaceutical and biotechnology companies.
- QbD elements such as Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Control Strategy are also required by US, EU and other regulators to be presented in a regulatory dossier to demonstrate that a product will be safe and effective.
- This dossier also should demonstrate that the product can be consistently produced over its life cycle. PAT is enabling next generation control strategies and continuous manufacturing.
- This course will take attendees through the journey of classroom presentations and case studies so that they will be prepared to participate in QbD related activities related to a biotech product.
What Will You Learn:
- Introduction to Q-b-D principles: A science- and risk-based approach
- Product understanding – Critical Quality Attributes (CQAs) – patient safety and needs
- Analytical QbD rationale approach to design and development of analytical methods
- Process understanding
- Development of Process and Analytical Control Strategy Including Process Analytical Technology
- 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
Who Should Attend:
- Scientists and engineers who are new to QbD and PAT and/or need an update in their knowledge of the subject
- Biomanufacturing supervisors and managers who need to better understand the challenges and opportunities of QbD and PAT
- Personnel such as QA/QC and validation professionals who support QbD and PAT but who may not be knowledgeable about execution of the processes they support
- Vendors who supply the industry with equipment and components
- Biomanufacturing industry personnel who are involved in upstream or downstream processing
- R&D scientists
- Chemical and biochemical engineers
- Cell biologists
- Group leaders, operation managers
- Pharmacists and other health professionals seeking to expand their understanding
Naveen Pathak, M.S., Takeda
Naveen Pathak is Director of Bio-Process Development at Takeda. Naveen currently leads a team that owns deployment of QbD and Process Validation. Prior to joining Takeda/Shire, Naveen 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 more than 25 years’ of experience in process development and technical services spanning non-clinical, clinical, and commercial manufacturing. He has a Master’s degree in Chemical Engineering from the University of Oklahoma and a graduate certificate in Quality and Regulatory Affairs from Temple University. Naveen is also actively engaged in teaching QbD-related courses at graduate schools in the US and is an Adjunct Faculty member at Keck Graduate Institute in Claremont, CA.
Cost Per Person: $2,550