QbD for Generics: Opportunities and Challenges
Wednesday November 28, 2012 | ARCHIVE NOW AVAILABLE!
Quality by Design (QbD) is a systematic approach to development that allows us to design Quality into the product. The benefits of QbD implementations are well understood by the generic industry.
Expectations for the generic industry have been mandated by the Office of Generic Drugs (OGD) over recent years at various meetings, workshops and roundtables. While developing high quality and robust products and processes, it is also essential to stay effective and efficient. Therefore, it is critical that we utilize and manage our expertise in the most effective way. We must also effectively apply statistical methodologies and tools to develop enhanced product and process understanding with a focus on materials attributes, formulation aspects and critical process parameters, as well as how to optimize and control them. This presentation will discuss an approach that will assist in achieving the desired balance between speed and excellence while implementing Quality by Design methodology in the generic industry.
Inna Ben-Anat, QbD Strategy Leader, Teva Pharmaceuticals
Inna Ben-Anat is a Quality by Design (QbD) Strategy Leader in Teva Pharmaceuticals USA. In this role, Inna has implemented global QbD training program, and is supporting R&D teams in developing Quality by Design strategies, optimizing formulations and processes and assisting develop product specifications. Additionally, Inna supports Process Engineering group with process optimization during scale-up and supports Operations in identification and resolution of any technical issues. Inna has extensive expertise in process development, design of experiments for process and product optimization, and statistical data analysis, and has more than 10 years of pharmaceutical development experience. Inna received her BSc degree in Chemical Engineering and ME degree in Quality Assurance and Reliability in Engineering from Technion-Israeli Institute of Technology.
|Date: November 28, 2012
Time: ARCHIVE AVAILABLE!
|Professionals from pharmaceutical, biotechnology and medical device companies with responsibilities and interests in the following areas:
- QbD/PAT Development and Implementation
- Process Engineering
- Quality Assurance (QA)
- Regulatory Affairs
- Pharmaceutical Research & Development
- Research & Development
- Quality Control (QC)
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