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Trainers

Ernie Hillier

EJH Consulting

Principal Owner


After 39 years at Waters Ernie has retired and has formed EJH Consulting with the focus on helping the industry continue to evolve in Process Analytical Technology to implement Continuous Manufacturing. During his career, the roles have been in new HPLC systems and chemistry evaluation, Product Marketing for Detectors, Operations as Manager of the Technical Product Management Group responsible for Quality. In this last role this experience has led to a better understanding of process which has led to his role as Principal Systems Product Manager for PATROL (PAT), Alliance and Breeze Systems. He has a BS degree in Chemistry and Biology from Northeastern University. Ernie is also on the Scientific Board of IPFAC and chair of the Advanced Separations Session. On subjects of PAT, QbD, and Continuous Manufacturing Ernie has presented at several conferences: IFPAC, IFPAC Cortona, IFPAC China, Pittsburg Conference, CPAC - University of Washington, CPAC Rome, Symposium on Continuous Reactor Technology for Industrial Applications, and Commercializing Continuous Processing in Pharma. In addition, Ernie has worked with Separations Science in organizing and facilitating both conferences as well as workshops.

Dr. Richard Ladd

Richard Ladd Consultancy and Laddavis Scientific

Owner and Director


An independent consultant to the pharmaceutical industryspecializing in Pharmaceutical development and manufacturing. Withmore than 35 years of Pharmaceutical industrial experience of allstages of new drug discovery, development, scale-up, manufacture,supply andcommercialization. He has an extensive expertise inanalytical, pharmaceutical development and regulatory CMCauthoring and reviewing regulatory submissions from first-in-humanto NDA/MAA as well as defending regulatory submissions andconducting prep-approval audit inspections of both manufacturingand analytical facilities.

COURSE NAME: Quality by Design (QbD) and Process Analytical Technology (PAT) for Pharmaceuticals & Biopharmaceuticals

This course aims to describe the key concepts that interplay in defining and implementing QbD and PAT towards development and manufacturing of pharmaceutical and biopharmaceutical products. This will be achieved via lectures and presentations of Industrial Case Studies and Participative Discussion and Assignments. Concepts discussed include: Critical Quality Attributes (CQA), Design Space, RiskAssessment, and Process Analytical Technology. The course will be practically oriented with examplesand specific guidance on how to apply these concepts in practice during Product Development and Manufacturing.



OUTCOMES of the Workshop:

At the completion of this workshop the participant will be able to:

  • Explain the link between CQAs and Design Space.
  • Describe what would he/she need to do differently in their present job in the QbD paradigm.
  • Explain the role of PAT in QbD paradigm.
  • Discuss the challenges of implementing QbD.
  • Explain the role of Risk Assessment and where to go to find the appropriate tool.
  • Challenges that one is likely to encounter when implementing QbD for commercialization of pharmaceutical products.