Overview

Quality by Design?

Is this just a buzz word? What is different from how development and manufacturing was performed in the past? Are there any advantages? And if so, which types of product benefit the most? What impact does this have on management, organisation, and investments?

Problems commonly encountered are:

• New technologies and continuous improvement cannot be implemented because regulatory requirements make quick changes to e.g. optimise production almost impossible.
• Very detailed manufacturing batch records in the dossier cause deviations and associated investigations even for minute interventions and make the batch record review a time consuming process.
• Compliance in some cases doesn't assure a quality product but reduces yield and increases costs.

Reaction by Regulatory Bodies:

FDA and EMEA have acknowledged these problems and embraced the PAT and developed the 21st century initiative. The goal being to allow industry having latest technology in place to produce high quality products with optimised processes at lower costs. They promise regulatory relief, if a Quality by Design concept was implemented.

Goal of conference:

Based on case studies it will be shown what it means to use a QbD approach:

• How to do it in practical terms.
• What impact it has on developing and manufacturing pharmaceutical products.
• What is the organisational impact on management, regulatory, manufacturing, QC, QA, and other functions.
• What are the proven advantages.

Practical Implementation of QbD:

There are essential aspects which have to be considered when implementing QbD. At the conference practical examples will be given by pioneers from industry and regulators for each of them:

• Determine critical parameters and quality attributes

Hear and discuss a Quality by Design Approach for a Freeze-Drying Process and see how such processes may benefit from these concepts. (by Stéphanie Passot, AgroParisTech / INRA, France)

Learn how to combine PAT and a mechanistic model in the manufacture of a biopharmaceutical Drug Substance. (by Janus Krarup, NovoNordisk, Denmark)

• Define and establish the Design Space

Get to know how to evaluate lyophilization robustness using a Design of Experiments. (by Romain Veillon, GSK, Belgium)

• Implement the Control Strategy

See how control strategiesfor containment manufacturing work, and the benefits achieved. (by Torsten Schmidt-Bader, NNE-Pharmaplan, Germany)

• Get Regulatory Relief

Hear from Industry and Regulators what it takes to get real-time release approved based on a QbD approach. (by Chris Dafforn, AstraZeneca, UK and Keith Pugh, Assessor, MHRA, UK)

Advantages of QbD approach:

The only reason to go with a QbD approach is the realisation of advantages. In particular regulators that have been exposed to Quality by Design settings from France, Sweden and the UK will point out:

• Regulatory relief:
  • more process flexibility - no deviations
  • continuous improvement of processes – no variations / changes
  • regulatory flexibility

Industry leaders coming from, e.g. AstraZeneca, Boehringer Ingelheim, GSK, Merck&Co., and NovoNordisk will present:

• Demonstrated advantage for production

1. continuous improvements without a long wait for regulatory approval

2. less deviations and investigations

3. almost instantaneous batch record review

4. lower costs

5. real-time release

Who Should Attend

Departments
Regulatory Affairs | QA/QC/IPC | Development | Manufacturing Operations | Engineering | Validation | Consulting

Job Functions
Pharmaceutical and Process Development | Chemical, Biochemical and Synthesis Development | Analytical Development | Manufacturing | Quality Management | Validation/Qualification Managers

Learning Objectives

At the completion of this workshop, participants will be able to:

• Define Quality by Design
• Explain how QbD applies to pharmaceutical processes
• Summarize the interconnections between QbD, risk assessment, design space, control strategies and process validation
• Understand the evolution of QbD and its tools as the pharmaceutical communities move forward
• Identify the challenges of implementing QbD into pharmaceutical processes
• Evaluate how global regulatory authorities are driving QbD

Contact

For conference information, contact:

PDA Europe gGmbH
Adalberstr. 9
16548 Glienicke/ Berlin, Germany
Phone: +49 (0) 33056-237710
Fax: +49 (0) 33056-237777
Email: info-europe@pda.org

For exhibition and sponsorship information, contact:

Astrid Guenther
Marketing Manager, PDA Europe
Tel: + 49 (0) 33056- 237711
Email: guenther@pda.org

Katharina Keisers-Engstfeld
Event Manager, PDA Europe
Tel: +49 (0) 33056-237714
Email: keisers@pda.org