Handling biological Raw Materials & APIs - Live Online Training
19 October 2027
Course No. 23200
Speakers
Dr Katja Aschermann
Astator
Raphael Parusel
TETEC
Dr Sven Deutschmann
Roche Diagnostics
- Regulatory Requirements and Classification - Microbiological Safety and Control - Selection & Qualification of Suppliers
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.
Objectives
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 limited written guidance on risk-based management of biological raw materials, European Biopharmaceutical Enterprises (EBE) has prepared a concept paper entitled “Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products”. Other approaches can also be helpful – for example, considerations from Annex 1 for products that need to be sterile or have a low bioburden claim, and QbD approaches for consistent product quality.
This Live Online Training is designed to gain deeper insight into the challenges such as mitigating risks of contamination and ensuring robust supplier selection and qualification. It provides industry professionals with the knowledge and skills needed to ensure compliance and optimise their processes for handling biological raw materials and their control strategies, including classification and regulatory aspects, raw material qualification and microbiological safety and viral contamination risk control strategies.
Programme
Classification and Regulatory Aspects of Biological Raw Materials (Katja Aschermann)
Starting Materials
Biological Raw Materials
Novel Excipients
Raw Material Qualification for Cell Therapies (Katja Aschermann)
From Risk Profile to Material Qualification
Examples
Quality Control of Raw Materials
Microbiological & Viral Safety: Contamination Risk Control Strategy
(Sven Deutschmann)
Contamination Risk: Understanding & Assessment
Prevention and Controls
Viral Safety Strategy
Monitoring & Testing (with RMM)
Suppliers – Selection and Qualification
(Raphael Parusel)
Sourcing
Development of a Supply Chain
Qualification
Auditing
Monitoring
Further Information
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 events 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.
Fees (per delegate plus VAT) ECA Members EUR 790 APIC Members EUR 890 Non-ECA Members EUR 990 EU GMP Inspectorates EUR 495 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate 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.
Conference language The official conference language will be English.
Testimonials
