Quality by Design for Chemical and Biotech Products – A hands-on course for the pharmaceutical industry and regulators
Sep 11 2013 12:30PM - Sep 13 2013 5:00PM | Pharmig Academy
In this short course the key elements of Quality by Design for small molecules and biotech products will be discussed. Participants will learn, with practical work on case studies (solid dosage form of a small molecule and manufacturing process for a biotech product), how to use Quality Risk Management (QRM), Process Characterisation, Design of Experiments (DoE), Development of a Design Space and Control Strategy, as well as the tools of Knowledge Management (KM). In the case studies all participants will prioritise the potential critical formulation and process parameters with QRM, propose a DoE to define the critical parameters and eliminate uncritical parameters. The knowledge gained will be used to establish a Design Space and essential elements of the control strategy. Knowledge Management will be introduced to keep the information and knowledge gained transparent and available for the full lifecycle of the product. The case study will demonstrate that a systematic approach to pharmaceutical development will be faster and will lead to robust processes. Potential internal savings will be discussed and the regulatory flexibility will be discussed with a key European regulator. The course will also give an overview on global requirements including new relevant EU regulations and discuss opportunities for an optimal QbD submission.
This course is a hands-on course full of practical work. It is necessary that you bring your laptop with you.
What You Will Learn
- Quality by design for biotech products and small molecules
- Prior Knowledge, Knowledge Management and QTPP Development
- Initial Risk Assessment (FMEA), Introduction to Process Characterisation and Design of Experiments
- Experimental Work, Multi-variate Data Analysis (MVA) and Knowledge Space Establishment
- Design Space Definition
- Control Strategy
- Technologies Assisting QbD Approach
- Regulatory Flexibility and QbD submission strategies
- Post-Approval Change Management Protocol
Who Should Attend
Pharmaceutical scientists, chemist, biologists and engineers. Experts from industry and regulators with experience in pharmaceutical, chemical and biotech development, manufacturing, quality assurance and CMC.
At the conclusion of this course, participants should be able to:
- Understand what QbD for biotech and small molecules is
- Define how critical formulation and process parameters are identified
- Use Quality Risk Management in the context of QbD
- Use tools of scientific process characterisation
- Develop a Design Space
- Develop a Control Strategy
- Develop a Knowledge Management structure
- Understand how to submit QbD data and get regulatory flexibility
Hotel & Travel
The DIA has blocked a limited number of rooms at the following hotel:
Tel.: +43 1 404 46 0
Fax: +43 1 408 83 92
at the rate of
EUR 110.00 per single room and EUR 130.00 per double room inclusive of VAT, service, taxes, and buffet breakfast.
To reserve a room, please contact the hotel with your credit card details at email@example.com with booking reference “DIA”.
Important: Please complete your reservation by 10 August 2013. Reservations received after this date will be subject to hotel availability and room rate may vary.
KUECHENGASSE 16, POSTFACH
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:
- Industry (Member/Non-member) = €200.00
- Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
- Tutorial cancellation: €50.00
If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.