Bars
GMP Courses and Conferences
Back
18/19 March 2025
Speakers
Dr Katja Aschermann, Astator
Melanie Braun, Labor LS
Stefan Gärtner, Labor LS
Dr Armin Hauk, Sartorius Stedim Biotech
Dr Ana Kuschel, West Pharmaceuticals Deutschland
Anna Liznar, PathoQuest
Raphael Parusel, Tetec
Melanie Braun, Labor LS
Stefan Gärtner, Labor LS
Dr Armin Hauk, Sartorius Stedim Biotech
Dr Ana Kuschel, West Pharmaceuticals Deutschland
Anna Liznar, PathoQuest
Raphael Parusel, Tetec
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.
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.
Programme
Classification and Regulatory Aspects of Biological Raw Materials
(Katja Aschermann)
(Katja Aschermann)
- Starting Materials
- Biological Raw Materials
- Novel Excipients
QbD Approach to Registration of Raw Materials
(Katja Aschermann)
(Katja Aschermann)
- Introduction to the QbD Approach
- Target Material Profiles and Critical Quality Attributes
- Development of a QbD Approach for Raw Materials
- Examples
Process-related Leachables
(Armin Hauck)
(Armin Hauck)
- What are Process Equipment Related Leachables (PERLs)
- Bioprocessing using Single Use Systems (SUS)
- Regulatory requirements
- The dedicated concerns - Extractables Studies for SUS
- The extrapolation of extractables data to PERL exposure data
- PERL in safety and risk assessment
- PERL mitigation concepts
The Search for Ideal Biologics Containment
(Ana Kuschel)
(Ana Kuschel)
- Materials types and requirements
- Selection criteria considerations
- Regulatory landspace overview
- Current solutions for biologics
Raw Material Qualification for Cell Therapies
(Katja Aschermann)
(Katja Aschermann)
- From Risk Profile to Material Qualification
- Examples
- Quality Control of Raw Materials
Microbiological Safety: Protection Strategies for Product Quality and Health
(Melanie Braun)
(Melanie Braun)
- Basic principles of industrial Hygiene
- Risk factors for microbiological contamination
- Case studies
- Prevention strategies, monitoring and controls
Viral Contamination Risk Control Strategy
(Anna Liznar)
(Anna Liznar)
- Regulatory aspects in viral safety of biological raw materials
- Viral risk identification with NGS
- Considerations for viral safety of biological raw materials used in ATMP production
Rapid Microbiological Control of Raw Materials
(Stefan Gärtner)
(Stefan Gärtner)
- General requirements for (rapid) bioburden, sterility and endotoxin Tests
- Handling of small and/or complex sample volumes
- Design of validation studies
- Overview of different rapid methods for different matrices
Combined Products: Ensuring Compliance and Quality
(Raphael Parusel)
(Raphael Parusel)
- Combined products (medical devices and medicinal products)
- CE labelling
- Legal manufacturer and Distributor
- Requirements of the MDR
- Requirements of ISO13485
Effective Storage Solutions
(Raphael Parusel)
(Raphael Parusel)
- GMP warehouse structure
- Documentation
- Storage of medicinal products and medical devices
- Hygiene and Monitoring
- Implementation of ERP systems
- GDP
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.