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.

Features

On-line & On-Demand OR Hybrid (On-Demand + Scheduled Live Sessions)

  • 12 Months Access

  • Discounted Renewal Options

  • Got Questions? Get Answers from the Instructors.

Corporate Discounts

Discounts are available when enrolling 5 or more students. Click below to send us an email and we'll develop a quote based on the number of subscriptions you require.

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. Assoc. 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 learnt 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 advance 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

    • Welcome and Introduction

    • Product Development CMC Pathway

    • Introduction to JMP

    • DoE for Biopharmaceutical Design & Development Projects: Full Factorial Experiments

    • Designing an Experiment & DOE Guidelines

    • Putting it all Together: CMC Strategy and DoE

    • Homework

  • 2

    Session 02

    • Introduction

    • Systems Thinking

    • CMC Pathway including TPP, QtPP and CQAs

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

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

    • DoE for Biopharmaceutical Design and Development Projects – Forward Selection

    • 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)

    • DoE for Biopharmaceutical Design and Development Projects: Ensemble Models

    • CMC Pathway, Mitigating Risk

    • QbD S0303 Homework

  • 4

    Session 04

    • Introduction

    • CMC: Process Characterization and Control Strategy

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

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

    • Homework

  • 5

    Session 05

    • Introduction

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

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

    • DoE for Biopharmaceutical Design and Development Projects: Fractionally Weighted Bootstrapping (JMP Pro)

    • CMC – Process Validation

    • 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.

Additional Details

Blend on-line/on-demand training with the opportunity to interact with your instructors.

  • Download Course Notes & Data

    Students are provided with Course Notes and step-by-step solutions to analytical exercises and homework. All example and exercise data is provided so you can practice what you learn.

  • Get 12 Months Access

    Watch material as often as you want, when you want it. Access can be extended at a discount beyond the first 12 months.

  • Connect with Experienced Instructors

    Are instructors have deep experience in the field 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.

Watch Intro Video

Introduction Video

Meet the instructors & Learn more about our Approach to Phase-Appropriate QbD