September 22-23, 2009 | Frankfurt, Germany
Are you a Linked In member and interested in attending this workshop?
Join the QbD Linked In group and post questions and discuss potential coffee table topics with other attendees and the Program Chairs.
Overview
Quality by Design: A step to saving costs
This workshop centers around parenteral manufacturing from API to drug product and how to reduce costs maintaining or even improving quality. It will offer you the unique possibility to get a step-by-step introduction into how Quality by Design (QbD) could help in that.
You will be exposed to the authors of EFPIA's mock document that mimics a hypothetical application. It reflects what would be done for a (bio-)chemical, pharmaceutical and analytical development conducted under a QbD approach for a biotech API and an injectable product. The document illustrates step by step what experiments were conducted to identify and define critical quality attributes and deduce critical process parameters. It leads you through the unit operations and the definition of their design space as well as the control strategy applied. You'll get:
- The latest news from the Yokohama ICH Meeting on Q8, Q9, Q10 and Q11
- A sneak peak on EFPIA's Mock documents for QbD applied to developing biotech and injectable products
- Regulatory expectations and experiences with QbD
- QbD and Real-Time-Release Testing
Having learned this, you will be able to identify cost reducing QbD elements that are applicable in your shop and to your projects.
Continuing on practical issues, the second day sees experts from industry telling about real case studies and specific aspects like:
- QbD - application to biotech processes and information transfer
- Case study of an integrated QbD approach for science- and risk-based process development from an API to a drug product
- QbD in formulation and process development for a freeze-dried parenteral, a case study made in cooperation with FDA
- Parametric/real time release testing achieved using rapid microbiology methods as a QbD tool
- QbD/PAT implementation in drug product manufacturing for an already marketed commercial product and the tools applied
Here, the very basic issues on cost and choice of investments, cost saving, and return on investment are illustrated and you will have a realistic view on the benefits that can be obtained. Meet and discuss these issues with regulators from AFSSAPS, PIC/S, MHRA and EMEA as well as industry champions.
A New Workshop Experience:
To maximise your benefits from attending, the workshop is designed to open for specific questions you might have. Therefore, coffee shop tables will be set up to pre-defined topics but also to topics participants are indicating during the event. All lecturers have committed themselves to be present and to discuss topics brought up. You are encouraged to join tables following your specific interests. This will enable the beginner as well as advanced practitioner in QbD to get the maximum return out of this event. Notes from all coffe shop tables will be taken and distributed to the participants after the event.
Goal of workshop:
This workshop is built to give you a complete picture around what was invested and what net gain obtained by practical examples as well as:
Principles:
- Get an update on the outcome of the ICH Yokohama Meeting related to the implementation of Q8, 9 and 10 and its impact on any organisation
- Hear real case examples from regulatory inspections and regulatory bodies on what they expect to see in QbD driven marketing applications and manufacturing sites
- Be introduced to an application based on QbD, like the EFPIA mock document for the S2 and P2 Chapters for biological and biotech APIs as well as injectables
Practice:
- How QbD was implemented in practical terms, the costs, the benefits and the net gain
- What was done in a QbD-based development
- What to do when implementing QbD in an existing manufacturing environment
- What are the proven advantages of QbD elements
- Attending this workshop will allow you to identify cost saving QbD
- elements and ways to implement them for your projects.
Your Input Required:
The workshop is organised in a way that sees lectures of experts in the morning sessions and open workshop tables in the afternoon. To benefit, we encourage you to send in your most burning questions and issues in advance. Those questions will be used to structure the workshop. Please also indicate, if you were willing to host a discussion table for one or all of the questions you have sent in. Please provide your inquiries to eck@pda.org in order to assure your questions and concerns are discussed.
Who Should Attend
Functions and Professionals concerned are:
- Regulatory
- Documentation
- Chemical/ Pharmaceutical/Analytical Development
- Pilot Plant and Commercial Manufacturing
- Engineering
- Validation
- QA/QC/QPs
Contact
For conference information, contact:
PDA Europe gGmbH
Adalbertstr. 9
16548 Glienicke/ Berlin, Germany
Tel: +49 (0) 33056- 237710
Fax: +49 (0) 33056- 237777
Email:
info-europe@pda.org
For exhibition and sponsorship information, contact:
Katharina Keisers-Engstfeld
Event Manager, Europe
Tel: + 49 (0) 33056- 237714
Email:
keisers@pda.org