QbD - Product and Process Optimization using Design of Experiments

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    “Very well presented and engaging.  The Course Director was an exceptional teacher of this material. The hands on access to relevant software and exercises helped solidify the knowledge gained.”


    John C., Engineer III, TARIS Biomedical

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Course Director

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Course Fee

$2650.00 Regular Registration

$2450.00 Early Bird Pricing (Register 30 Days in Advance)

Course Description

Quality by Design (QbD) means that, starting from the very first development step, products and processes are designed in a way to ensure a high level of quality and reliability. One of the main QbD tools is statistical Design of Experiments (DoE), which enables to perform the necessary experiments in an efficient and structured way. This constitutes the most effective manner to identify the Critical Process Parameters (CPP’s) and Material Attributes (CMA’s) that, together, influence most the quality characteristics of highest concern, the so-called Critical Quality Attributes (CQA’s). Of course, the methodology can also be applied to optimize existing products or processes.


This Quality by Design and Design of Experiments pharmaceutical course gives a comprehensive introduction to statistical DoE: on the one hand, the statistical background is explained, on the other hand, the methods are illustrated with examples from the pharmaceutical and chemical industry, and their application is trained with many exercises based on real-world case studies using a DoE software tool. A part of the last afternoon is reserved for discussing the participants’ own applications. The practical aspects are addressed at regular intervals throughout the whole course duration, so that the course overall proposes a balanced combination of methodological knowledge and practical aspect.

Topic areas to be discussed include, but are not limited to:


  • The importance of Quality by Design (QbD) as part of an efficient QA strategy
  • DoE vs. one-factor-at-a-time
  • The sequential approach of DoE: screening, modelling and optimization – which design in which context?
  • Definition of a practical problem as the first step of the application of DoE
  • Factor screening and modelling: how to identify the Critical Process Parameters (CPP’s) and Material Attributes (CMA’s) as well as their interactions
  • Optimization of a response variable with response surface models
  • Graphical visualization and interpretation of the results
    DoE for formulations
  • Defining the Design Space
  • Robustness issues
  • Accounting for real-world challenges: complex restrictions, unsuccessful experiments

Who Should Take This Process Optimization and Quality Strategies Course? 

This comprehensive 20 hour design of experiments certification course is designed for chemists, engineers, pharmacists and biotechnologists in research, development and production, as well as for laboratory staff involved in the development or optimization of products and processes. The course covers active ingredients as well as formulated products and is of interest not only to the pharmaceutical and biotechnological sectors, but also to scientists working in the chemical and cosmetics industry.


No previous statistical or mathematical knowledge is necessary for this product and process optimization Design of Experiments training. Since the knowledge acquired is software-independent, the training will be of great benefit to anyone who intends to apply DoE or wants to do it better, whichever software tool he/she uses, even if a specific user-friendly tool (the DoE expert system STAVEX) is employed in the course to highlight the practical aspects of the methodology.

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  • Learning Objectives

    By the end of this Quality by Design pharmaceutical development course, you'll be able to:  


    After completing the course, the participants will have a thorough understanding of the concepts of statistical Design of Experiments (DoE). They will have gained confidence thanks to the many practical exercises, so that they can solve practical problems easily and efficiently in their daily work, when developing or optimizing products and processes in the QbD context. Among the advanced topics, the participants will in particular learn how to deal with typical complex practical situations such as the simultaneous optimization of several potentially contradictory Critical Quality Attributes (CQA’s), the optimization of formulations or the consideration of technical difficulties like an imprecise setting of the process parameters.

  • Agenda


    Background

    • Importance of Quality by Design (QbD) as part of an efficient QA strategy
    • Role of QbD / DoE within the Six Sigma framework
    • Regulatory aspects

    Concepts of Statistical Design of Experiments

    • Introduction
    • DoE vs. one-factor-at-a-time
    • Strategic approach in phases: screening, modelling, optimization

    DoE in Practice

    • User input: definition of response variables and factors
    • Effects and interactions

    Modelling

    • Full and fractional factorial designs
    • Selection of an appropriate design
    • Analysis of the experimental results with multiple linear regression
    • Graphical visualization and interpretation

    Modelling (cont.)

    • Numerical and graphical assessment of the model quality
    • Analysis conclusions

    Specific Issues with Formulation Problems

    • Concepts and definition of restrictions
    • Designs for formulation problems
    • Result analysis and interpretation

    Optimization

    • Optimization designs
    • Building response surface models to identify best settings, graphical interpretation
    • Confirmatory experiments

    Screening

    • Selection among many factors
    • Screening designs
    • Analysis with the half-normal plot

    Simultaneous Optimization of Several Response Variables

    • Target optimization
    • Determining the best compromise and the Design Space with the desirability function

    Accounting for Real-World Challenges

    • Experimental restrictions, trend
    • Handling of violated factor settings
    • Unsuccessful experiments

    Practical Recommendations


    Discussion of the Participants’ Own Applications

    • Questions & Answers

  • Testimonials

    “Very well presented and engaging.  The Course Director was an exceptional teacher of this material. The hands on access to relevant software and exercises helped solidify the knowledge gained.”

    John C., Engineer , TARIS Biomedical

FAQs

  • We already have existing products. Is this course relevant for optimizing existing products and processes, or is it designed only for new development?

    This course applies to optimizing existing products and to new development. While QbD principles are most commonly associated with new product development, this Design of Experiments and statistical analysis training is equally effective for optimizing products and processes already in production. 

  • Our team works in cosmetics rather than pharmaceuticals. Is this course still applicable to our industry?

    Yes. While the course is rooted in pharmaceutical and biotechnical contexts, the QbD and DoE methodology we teach is applicable across industries. Examples and case studies drawn from the chemical and cosmetics industries are incorporated throughout.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.