Handling biological Raw Materials & APIs - Live Online Training
18/19 March 2025
Course No. 21968
Speakers
Dr. Katja Aschermann
TETEC
Dr Armin Hauk
Sartorius Stedim Biotech
Dr Ana Kuschel
West Pharmaceutical Services
Melanie Braun
Labor LS
Anna Liznar
PathoQuest
Stefan Gärtner
Labor LS
Raphael Parusel
TETEC
All times mentioned are CET.
Objectives
This live online training is designed to address challenges such as mitigating risks of contamination, degradation and supply chain disruption. It provides industry professionals with the knowledge and skills needed to ensure compliance and optimise their processes for handling biological raw materials and active pharmaceutical ingredients.
Background
Raw materials, excipients and other products used in the manufacture of biologics must be well understood in terms of their role in the manufacturing process. Particularly in a GMP regulated environment, these raw materials, components and excipients require thorough control for consistent quality.
Therefore, all critical quality attributes should be known and appropriate risk mitigation and control strategies should be established. Since there is currently less written guidance on risk-based management of biological raw materials, European Pharmaceutical Enterprises, EBE, has prepared a concept paper entitled “Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products.”
But other approaches can also be helpful - a look at Annex 1 for products that need to be sterile or have a low bioburden claim. Or the QbD approaches for consistent quality of products.
Target Group
This training will be highly valuable for:
Laboratory managers
Quality control managers
Analytical scientists
Senior laboratory personnel
QA Units
Qualified Persons (QPs)
It is designed for professionals from biopharmaceutical companies, ATMP developers, and manufacturers. Additionally, the training is relevant for employees of contract laboratories involved in method development, control testing, and quality assurance.
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.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF