Quality by Design & Process Analytical Technologies

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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

Instructor Bio
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

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