Course Overview

Experienced Instructors, Effective Methods

Phase-Appropriate Quality by Design (QbD) is a systems approach to drug development and manufacturing that mitigates risk and facilitates regulatory compliance and successful outcomes.

The Phase-Appropriate approach emphasizes capturing data and building models in earlier phases, rather than having to resolve unforeseen problems later in development.

This new course provides in-depth learning and practical examples in applying both QbD and Design of Experiments techniques in chemistry, manufacturing, and control (CMC) process development.

A successful Quality by Design program combines advanced knowledge of both statistical methods and CMC to produce predictive models, which are vital for process design and process characterization.

Course Delivery Formats

We offer on-demand as the standard delivery format with additional hybrid format options.

  • 12 months of on-demand access

  • Hybrid option for single and group registrations: virtual office hours with instructors in real time

  • Hybrid option for group registrations: real-time tutorials with an in-house subject matter expert from your company

Corporate Discount Plan

Save more when enrolling group registrations of five (5) or more from your company. Get in touch to receive a quote and discover more about the hybrid options for enhanced group learning.

Approach

Combining CMC with The Most Effective DOE Methods

Our training approach will be from the CMC perspective, jointly led by Tiffany Rau, PhD, a well-respected expert in CMC process development, Philip Ramsey, PhD, a senior statistician with deep experience in pharmaceutical and biotechnology and a university lecturer in statistics and mathematics, and Wayne Levin, a certified JMP instructor.

Together, they will be demonstrating tools and methods that are specifically geared to scientists and engineers engaged in QbD and can be readily applied in their work.

This course includes step-by-step instructions for all demonstration and practice exercises. Our hybrid approach involves scheduling your team to view segments with live sessions with the instructors for discussion and questions.

What past students have said

Applying New Skills to Everyday Workflow

E.Y., Associate Director, Process Characterization

This Phase-appropriate QbD course integrates CMC, DOE and QbD as a holistic approach that stays within the regulatory expectations at each phase of the development process for complex biological drugs. I found it very rewarding to attend the training and learned the new skills to apply this approach to everyday workflow throughout different lifecycle stages of product and process. The course covers a lot of content and some topics can move to advanced training, such as modern DOE and product characterization.

Loved Presentation

S.T., Process Development Engineer

Overall, loved the way it is presented. Very clear with a bit of humor every now and then.

Course curriculum

  • 1

    Session 01

  • 2

    Session 02

    • Introduction

    • Systems Thinking

    • System Thinking Review

    • CMC Pathway including TPP, QtPP and CQAs

    • CMC Pathway Review

    • DoE for Biopharmaceutical Design and Development Projects: Predicting Physical System Behavior

    • Predicting Physical System Behavior Review

    • DoE for Biopharmaceutical Design & Development Projects: Building Predictive Models

    • Building Predictive Models Review

    • DoE for Biopharmaceutical Design and Development Projects – Forward Selection

    • Forward Selection Review

    • QbD S0205 Homework

    • QbD S0206 Row States

  • 3

    Session 03

    • Introduction

    • DoE for Biopharmaceutical Design and Development Projects: Best Subsets Regression

    • DoE for Biopharmaceutical Design and Development Projects: Penalized Regression (JMP Pro only)

    • Penalized Regression Review

    • DoE for Biopharmaceutical Design and Development Projects: Ensemble Models

    • Ensemble Model Review

    • CMC Pathway, Mitigating Risk

    • Mitigating Risk Review

    • QbD S0303 Homework

  • 4

    Session 04

    • Introduction

    • CMC: Process Characterization and Control Strategy

    • Process Characterization and Control Strategy Review

    • DoE for Biopharmaceutical Design and Development Projects: Response Surface Designs and Models (RSM)

    • Response Surface Review

    • DoE for Biopharmaceutical Design and Development Projects: Working with Multiple Responses, Characterization, Optimization

    • Multiple Response Characterization & Optimization Review

    • Homework

  • 5

    Session 05

    • Introduction

    • DoE for Biophamaceutical Design and Development Projects: Optimal Experimental Design

    • Optimal Experimental Design Review

    • DoE for Biopharmaceutical Design and Development Projects: Definitive Screening Design

    • Definitive Screening Design Review

    • DoE for Biopharmaceutical Design and Development Projects: Self-Validating Ensemble Models (Fractionally Weighted Bootstrapping (JMP Pro) )

    • Self-Validating Ensemble Model Review

    • CMC – Process Validation

    • Process Validation Review

    • Homework

    • Where do we go from here?

Instructor(s)

Founder, Rau Biotech LLC

Tiffany Rau

Dr. Tiffany Rau is an expert and leader in R&D, process development, and commercialization (manufacturing in compliance with cGMP) of biopharmaceuticals and industrial biotech. Tiffany has been instrumental in designing and leading initiatives to bring R&D and manufacturing together to increase speed to market and minimize technology transfer challenges. Dr. Rau has given over 75 invited speaking engagements internationally, with a focus on delivering current and next-generation products from R & D to commercialization/post-commercialization.  Tiffany is also active in the scientific community and is Program Chair for the Recent Advances in Fermentation Technology meeting (2015-2019) and has organized numerous sessions at the SIMB National Meetings (Society of Industrial Microbiology and Biotechnology) and ECI Cell Culture Engineering meetings. She was also part of the inaugural organizing team for ECI’s Microbial Engineering Conference in 2018 and continued on the organizing committee for 2020.

Senior Data Scientist, Predictum Inc.

Philip Ramsey

Dr. Philip Ramsey is a Senior Data Scientist and Statistical Consultant at Predictum Inc. He provides data science consulting services for our software products and several custom projects of integrated analytical systems, specializing in modern experimental design and analysis strategies and application of machine learning to science and engineering.  In addition, Phil is a Professor in the Department of Mathematics and Statistics at the University of New Hampshire (UNH) where he teaches courses at the undergraduate and graduate level in design of experiments, machine learning, and statistical methods for quality improvement.  Phil has held the following relevant industrial positions: Senior Engineer for Materials and Processes Development, McDonnell Douglas, St. Louis, MO; Staff Scientist/Statistician, Alcoa Technical Center, Pittsburgh, PA; and Statistician/Senior Engineer, Rohm & Haas Electronic Materials (now Dow), Marlboro, MA. Dr. Ramsey has a Ph.D. in statistics from Virginia Polytechnic Institute and State University.

President & CEO, Predictum Inc.

Wayne Levin

Wayne Levin is the President and CEO at Predictum. He has provided executive leadership to the Predictum team for over 28 years. He is passionate about delivering robust and reliable analytical solutions to improve productivity and accelerate operational performance and innovation in engineering, science companies, and research to companies in various industries. Wayne also leads statistical training workshops and presents at speaking engagements.  Wayne has forged a strong and longstanding partnership with JMP, a business unit of SAS Institute, as a major JMP customization and training partner. Wayne earned a B.A.Sc. in Industrial Engineering from the University of Toronto, and an M.A.Sc. in Engineering with a focus on research methods from the University of Waterloo.

Benefits

Blend online, on-demand training with the opportunity to interact in real time with your instructors.

  • Download Course Materials and Example Data

    Students are provided with course materials, step-by-step solutions to analytical exercises, and homework assignments. All example data and exercises are provided so that you put what you've learn into practice right away.

  • Get 12 Months of On-Demand Access

    View recorded course lectures as often as you want and when you want. Access beyond the first 12 months can be extended at a discounted rate.

  • Connect with Experienced Instructors

    Our instructors have deep industry experience in the real-world use of QbD. Both Dr. Tiffany Rau and Dr. Philip Ramsey are published authors and regular speakers at pharmaceutical and biotechnology conferences. They are available to answer your questions.