Smart QbD™ Webinar: Applying Quality by Design
The director of QBD’s subsidiary in Spain – Alicia Tébar – presents a webinar on the practical application of Quality by Design.
Smart QbD™: Applying Quality by Design efficiently to your products
The QbD methodology goes beyond development and is changing the orientation of pharmaceutical quality systems. Quality begins with design, but extends over the entire commercial life of the product. Continuous verification and continuous improvement require good planning and resource sizing to avoid frustration and procedures that are not applicable in practice. In this Webinar we will describe the methodology that we have been applying for more than 10 years and that we have called SMART QbD™
The objective is to achieve an efficient implementation of Quality By Design (QbD) adapted to the available resources and taking into account the constraints imposed by business objectives, “time to market” and the maintenance of the risk management system.
Managing Partner of QBD Pharmaprojects Spain, a subsidiary of the QBD Group in Spain and member of the Management Committee of ISPE Spain.
Graduated in Chemistry from the University of Barcelona, she has more than twenty years of professional experience in the pharmaceutical industry as manager of quality control and research and development (R&D). This experience in quality and equipment management in multinational companies has allowed her to gain an overview of regulatory requirements and drug manufacturing needs.
Passionate about quality, she became Six Sigma Black Belt specialized in process improvement and implementation of Quality by Design. Since then, she has assisted multiple pharmaceutical companies in the application of QbD, as well as in the training of technical personnel in risk analysis, DoE and statistics, technical support for QbD pilot projects, design of plans for continuous process verification, univariate and multivariate statistical study of historical process data, etc.
He has work experience in multiple countries: Spain, France, Germany, Denmark, Romania, Mexico, Uruguay, Brazil and India.
So far 2018 she lectured at the Colegio de Farmacéuticos de México and gave a course in Belgium on Cell By Design.
The QBD company.
The international consultancy firm founded in 2011, has more than 150 consultants at your service and offers companies specialized knowledge and experience in the field of pharmaceutical development, technology transfer, validation and quality management. In addition to, having a business unit for the development of customized software solutions in accordance with FDA 21 CFR part 11, QbD Software.
The QBD Group has offices in Belgium, Holland, Spain, Mexico and Colombia.
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