The training deals with the special features production and quality control of small and very small batches down to batch size 1. The pharmaceutical industry is increasingly faced with the following questions how these products can be economically manufactured and economically. The seminar provides answers to these questions and a precise overview of authorization issues, regulatory environment, manufacturing methods approaches, quality control through to the details from the transition from pre-clinical to commercial stage.
Background
While constant efforts are being made to increase the production of many medicinal products, this is not possible for all of them, as various further developments, such as improved diagnostics or personalized medicine, as well as economic constraints and the diversification of production for different target markets are leading to ever smaller batches down to a batch size of 1 in the case of patient-specific products. Due to developments in recent years and the increasing number of new personalized medicines, the issue of small batches with a worst-case batch size of 1 has become more important. The EDQM, the FDA and other institutions are attempting to create uniform regulations for personalized products with new draft guidelines. However, batch size is rarely considered.
The influence of batch size on the manufacture of a product is immense and affects several areas and should be considered at an early stage. These changes require new concepts in the areas of analysis, filling, production planning and processing and much more.
Target Group
Employees in development, production and quality control of small batches, personalized medicine, specific ATMPs, contract manufacturing and testing.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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Testimonials
Seminar Programme as PDF