Dr Katja Aschermann
Astator
Referent:innen
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
Zielgruppe
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.
Zielsetzung
This 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.
Programm
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
Weitere Informationen
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Contacts
Questions regarding content:
Mr Clemens Mundo, +49 (0)6221 84 44 42, mundo@concept-heidelberg.de
Questions regarding organisation:
Ms Manuela Luckhaupt, +49 (0)6221 84 44 66, luckhaupt@concept-heidelberg.de
Recording from 18/19 March 2025
Duration of the recording: approx. 6 h 30 min.
Duration of the recording: approx. 6 h 30 min.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Regular Fee*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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E-Mail: info@concept-heidelberg.de
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