QUALITY BY DESIGN - DMU

1QUALITY BY DESIGN For the Pharmaceutical Industry

QUALITY BY DESIGN For the Pharmaceutical Industry

The science and risk-based approach to pharmaceutical development and manufacturing technologies

MSc Distance Learning Course


De Montfort University (DMU), in partnership with leading industrial corporations, is offering a unique MSc course in Quality by Design

Senior professionals from companies including AstraZeneca, Pfizer, GlaxoSmithKline,Bristol-Myers Squibb, Novartis and Baxter have been working alongside DMU’s experts in Pharmacy education to deliver postgraduate training in Pharmaceutical Quality by Design. We work as a multi-disciplinary team with a fully integrated approach from companies represented by:

The term Quality by Design was first defined in the International Conference on Harmonisation (ICH) guideline Q8 Pharmaceutical Development (ICH, 2009) as follows:

“Quality-by-Design (QbD) is a systematic approach to development that begins with predefined objectives, emphasises product, process understanding and process control, based on sound science and quality risk management.”

Since 2011, using a flexible e-learning platform, we have been providing students with interactive, high quality learning materials, which have been specifically created as a unique collaboration between industry and academia.

Regulatory Agencies

Multinational Pharmaceutical

Companies

Excipient and Equipment

Manufacturers

Consultants and SMEs

Data Analysis and Software Specialists

Engineering Companies


Module 1 Regulatory Guidelines,

Principles and Tools of QbD

Module 2The QbD Product

Development Roadmap

Module 3Quality by Design

in Practice

Module 4Manufacturing,

Process Controlsand Inspection

Module 5 & 6 Quality by Design for Biopharmaceuticals/Research Methods

Module 7 Dissertation

PG Cert 60 Credits

PG Dip 120 Credits

MSc 180 Credits

CPD Route (individual modules)

Contact us – we will be delighted to discuss how our expertise in Quality by Design can help you and your company. Email: [email protected]

Study Options


Module 1 - Regulatory Guidelines, Principles and Tools of Quality by Design

ContentThis module gives a general introduction to the four main areas: ICH guidelines includingprocess validation and regulatory considerations, risk assessment, design of experiments, process analytical technology and multivariate analysis.

Students will learn from industrial experts how to apply the core of QbD principles and tools in a systematic manner from quality target product profile (QTPP) to Continuous Improvement.

Fundamentals of Experimental

Design (DoE)

Manufacturing and Facilities

Quality RiskManagement

ICHGuidelinesIntroduction

Regulatory Considerations More on DoE

Introductions to Process

Analytical Technology (PAT)

Modelling Multivariate Analysis

These principles are underpinned by science, pharmaceutical quality systems, quality risk management and knowledge management. This module introduces tools that facilitate the implementation of the QbD approach such as: process analysers; design of experiments; and multivariate analysis.


Who is teaching?*

Bruce Davis Global Consulting

Dave Holt AstraZeneca

Sean Hale Consultant

Gerry Steele PharmaCryst Consulting Ltd

Line Lundsberg Lundsberg Consulting

Andrew Dennis Bristol-Myers Squibb

Brad Swarbrick CAMO Software AS

Ian Cox JMP Division of SAS

Martin Owen, Kate Llewellyn, Gill Turner GlaxoSmithKline

Claire Beckett and Eric Johansson MKS Umetrics

Richard Funnell MHRA

Gustavo Marco and Mustafa Zaman MHRA


Module 2 - The Quality by Design Product Development Roadmap

ContentThis module gives a general introduction to the four main areas: design options, formulation and process development, design space and control strategy. This also includes key areas which impact product or process design such as, biopharmaceutics, materials characterisation, excipient properties and Active Pharmaceutical Ingredient (API) considerations.

Who is teaching?*

James Kraunsoe, Talia Buggins and Kathryn Gray AstraZeneca

Roger Weaver Pfizer

Mathias Walther Pfizer

Elaine Stone Merlin Powder Characterisation

Brian Carlin FMC Biopolymer

Ian Robertson Colorcon

Claire Beckett and Erik Johansson MKS Umetrics

Lloyd Stevens, Vanessa Zann, Zoe Kane and Alison Connor Quotient Clinical

Maureen Mistry and Thorsten Cech BASF

Module Outline

Design Options

Formulation and Process Development

Design Space and Control

Strategy

Biopharmaceutics

Material Characteristics and Excipents

Active Pharmaceutical Ingredient (API) Considerations


Module 3 - Quality by Design in Practice

ContentPractical examples will be given across a diverse range of product types such as inhalation, sterile products, and polymer excipients. The use of QbD principles in analytical method development will also be covered. This module will help learners identify how they can apply QbD principles in their work environment.

Who is teaching?*

Thomas Dassinger Evonik Industries, AG

Andy Rignall AstraZeneca

Paul Matejtschuk NIBSC / MHRA

Matthew Brown Lyosolutions

Pauline McGregor PMcG Consulting

Tim Lukas and Rachel Brody Pfizer

Claire Beckett and Erik Johansson MKS Umetrics

Sterile Products

Freeze Drying

Inhalation Products

Case Studies

RiskAssessment

Film Coating

Analytical Methods


Module 4 - Quality by Design in Manufacturing, Process Controls and Inspection

ContentDuring this course, students will study process design as the initial stage of process development, creating a model of the commercial manufacturing process to include the intended scale of manufacturing. This module presents factors that need to be considered for the design, including facility, equipment, materials transfer, and manufacturing variables with particular focus on powder technology.

The selection of ‘type’ of process will depend on the product design and properties of the materials. Using current state-of-the-art techniques to support QbD principles in process development and optimisation of manufacturing, will be an important part of this module content.

Who is teaching?*

Trevor Page and Jurgen Boeckx GEA Pharma Systems

Keith Smith Perceptive Engineering

David Holt and Bindhu Gururajan AstraZeneca

Penny Butterell Pfizer

Richard Funnell MHRA

Process Engineering

Process Controls

Continuous Processing

Continuous Quality

Verification

Regulatory Considerations


Module 5 - Quality by Design for Biopharmaceuticals

Who is teaching?*

Sajal Patel and Gisela Ferreira Medlmmune

M. Amin Khan, Cristiana Campa, Mikkel Nissum and Alexander Pysik Novartis Vaccines

Keith Chidwick MHRA

Bruno Boulanger Arlenda

Lisa Hardwick Baxter

Karen Bossert Lyophilization Technology

David Paolella GlaxoSmithKline

Sumit Luthra Pfizer

ContentThis module introduces the application of Quality by Design to biopharmaceuticals through a series of case studies, which cover a diverse range of applications.

Module Outline

QTPP Risk Analysis CQAs, CPPs

DoE Bioassays Multivariate Analysis

Control Strategy

Regulatory Considerations

Freeze Drying Case Study

QbD to vaccine development


Module 6 – Research Methods

ContentDuring this course, students will learn to apply methodologies including risk assessment, design of experiments (DoE), data collection, processing and analysis. The importance of design of experiments concept will be discussed. Issues are primarily illustrated through examples from industrial cases. Students are encouraged to share and draw upon their experiences in this module as part of the learning process.

Who is teaching?*

Walkiria Schlindwein Professor of Pharmaceutics

Irina Ermolina Senior Lecturer in Pharmaceutics

Martin Owen Insight by Design LTD

Introduction of Research

Methods

Library Resources

Design of Experiments (DoE)

Higher Education

Assignment Toolkit


Module 7 – DissertationOverviewThe purpose of this module is to provide students the opportunity to consolidate their knowledge of Quality by Design applied to pharmaceutical science or related industries by carrying out a research or development project in an area of their interest.

There are no recorded lectures within this module. Students will be assigned a supervisor who supports them throughout the project. As part of the research methods module, students will have completed the vast majority of their literature review. From this point they will be ready to start their project. The suggested timeline for project work is between 30 to 40 weeks.

The dissertation will require the application of many elements of the skills and knowledge acquired in the other modules of the programme. Students will be expected to apply the knowledge they have gained across the modules to a real-life or simulated situation.

ContentThe work will involve data collection and analysis. During this time, each student will be expected to gather data and to plan ongoing strategies for continued study. The final dissertation will be around 15,000 words, excluding abstract, references and appendices. The report should be written in a scientific style.

Who are the supervisors?Supervisors are chosen by the student from industry based on their areas of expertise.


Key InformationDelivery mode – online onlyDelivery through the DMU bespoke e-platform is completely flexible to the student. They are able to pace their learning to suit individual timeframes, within the suggested timeline of 15 - 20 weeks per module (30 - 40 for module 7).

For employers, online training offers flexibility. Students can develop their skills within their workplace environment.

Who would benefit from the course?This course is designed for graduates and postgraduates (biologists, chemists, chemical engineers, pharmacists, physicists, material scientists) who aspire to learn more about developing and manufacturing medicines using Quality by Design principles.

CostFor more information please see our website.

How to ApplyPlease contact [email protected] if you have any questions regarding the course or would like to speak to someone about your options.

Details on how to apply can be found at dmu.ac.uk/qbd-industry

*Please note the company names are correct at the time of filming each module. Individuals may have subsequently left these companies.

http://dmu.ac.uk/qbd-industry

http://[email protected]



For more information please contact: E: [email protected]: dmu.ac.uk/qbd-industry

Hawthorn BuildingThe NewarkeLeicester LE2 7BY February 2021


QUALITY BY DESIGN - DMU

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