Nov 3 2011 8:00AM - Nov 4 2011 5:00PM
CMC,Manufacturing,Quality Assurance/Quality Control,Regulatory Affairs,Research & Development
This is a joint DIA/Pharmig training course.
In this short course the key elements of Quality by Design, e.g. 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 will be introduced. In a case study 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 gained information and knowledge 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 relevant EU regulations and discuss opportunities for an optimal QbD submission.
Prior Knowledge, Knowledge Management and QTPP-Development
Initial Risk Assessment (FMEA), Introduction to Process Characterisation and Design of Experiments
Experimental Work, Multivariate Data Analysis (MVA) and Knowledge Space Establishment
Design Space Definition
Technologies Assisting QbD-Approach
Regulatory Flexibility and QbD Submission Strategies
Post Approval Change Management Protocol
At the conclusion of this course, participants should be able to:
Understand what Quality by Design is
Define how critical formulation and process parameters are identified
Use of 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
Pharmaceutical scientists and engineers. Experts from industry with experience in pharmaceutical development, manufacturing, quality assurance and CMC regulatory experts.
The “Quality by Design: A Hands-on Short Course for Pharma” training course has been accredited with 2 ECTS credits. These equals a workload of 50-60 hours that would be needed to achieve the learning outcomes that enables the participants to understand and use the Quality by Design approach. As this course is a combination of intensive theory lectures together with effective practical examples promoting an interactive learning process, the learning objectives are achieved within the two course days.
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 12 credits.
ELISABETHENANLAGE 25, POSTFACH
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52