In this hands-on course the key elements of Quality by Design for small molecules and biotech products will be discussed. Participants from pharmaceutical, biotech and generic industry as well as regulators 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, execute and evaluate 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 and optimisation, respectively, will be faster and will lead to robust processes. Potential internal savings 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 has limited capacity. Please register early.
What the participants from previous QbD courses say:
"This training is very good and supportive for my job"
"Interesting to hear how to use QbD in regulatory submission"
"Case studies are good"
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 StrategyTechnologies 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 (pharmaceutical companies, biotech companies, generic 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
Plan and evaluate basic experimental designs
Develop a Design Space
Develop a Control Strategy
Develop a Knowledge Management structure
Understand how to submit QbD data and get regulatory flexibility
This course is a hands-on course full of practical work. It is necessary that you bring your laptop with you.
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
Hotel & Travel
The training course will take place at:
DIA has blocked a limited number of rooms at the following hotel:
Tel.: +43 1 404 46 0
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 firstname.lastname@example.org with booking reference “DIA”.
Important: Please complete your reservation by 22 August 2014. Reservations received after this date will be subject to hotel availability and the room rate may vary.