Dr. Marcel Günther
Regierungspräsidium Tübingen
Referent:innen
Dr. Matthias Leitritz
Rentschler Biopharma
Dr. Marcus Fido
Mfi Bio-Consulting
Stephan Löw
CSL Behring
Friederike Wedelich
Regierungspräsidium Tübingen
Zielsetzung
This Education Course concentrates on regulatory and practical requirements regarding biopharmaceutical production. From clinical phases to routine manufacturing, practical examples and case studies will facilitate the implementation of GMP in your daily Business.
The course will treat the topics of routine inspection from regulatory bodies and customers, quality assurance and quality control as well as in laboratory and production.
The course will treat the topics of routine inspection from regulatory bodies and customers, quality assurance and quality control as well as in laboratory and production.
Speakers from manufacturing, laboratory, consultancy and authority will show their expectations as well as their experiences in GMP implementation.
Hintergrund
In defiance of all throwbacks in the last years, a progression of new approvals of biopharmaceuticals is expected. Furthermore after the end of the protection of patents, biotechnical generics will be added.
Especially in the field of biotechnology you find often challenges to fulfil the regulatory requirements on production and quality assurance.
Industry and authorities have to face the new and expected changes in the regulatory Guidelines.
Especially in the field of biotechnology you find often challenges to fulfil the regulatory requirements on production and quality assurance.
Industry and authorities have to face the new and expected changes in the regulatory Guidelines.
Zielgruppe
This course is advisable to people who
- are involved in regulatory inspections,
- work in quality units at biotech companies,
- implement GMP in biotech production,
- are responsible for GMP requirements pre-approval phases.
Date / Venue / Presentations / Certificate
Tuesday, 27 May 2025, 09.00 h – 17.30 h
(Registration and coffee 08.30 h – 09.00 h)
Wednesday, 28 May 2025, 08.30 h – 17.30 h
Doubletree by Hilton Vienna Schönbrunn
Schlossallee 8
1140 Vienna, Austria
Phone +43/1/89110
Email info@doubletree-schonbrunn.at
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
GMP Guidelines for Biopharmaceuticals – a Brief Summary
- Relevant international regulations
- European biotech guidance
- Recent developments & possible impacts
GMP Requirements Applying to Biotechnological Investigational Medicinal Products (IMPs of Clinical Phases I-III & APIs for use in IMPs)
- EU regulations & guidances
- Examples of national regulations
- State-of-the-art manufacturing for clinical phases
Development of Biopharmaceuticals – GMP, Regulatory Aspects and Inspection & Audit Experiences
- EU and US guidances related to clinical trials GMP/CMC incl. Annex 13 update
- CDMO considerations on specifications
- Inspection and audit experiences “pre-approval”
Development, Qualification and Validation of Process Analytics for Biopharmaceuticals
- Relevant guidelines
- Phases of product development / testing requirements
- Method portfolio/method development / method qualification / method validation
- Product analytics & QC methods for product characterization
- Relevant guidelines & publications
GMP Inspections in Biopharmaceutical Production
- Inspections of biopharmaceutical companies
- Focus & discussion points during inspections
- Clean room classes for biotech facilities
- Open vs. closed processing
- Single- vs. multi-purpose equipment
- Cell banking activities
- Inspector’s experience, examples of observations
Process Transfer from Development to Commercial Production from a Quality Perspective
- Definition and types of Transfers
- Specific quality considerations for transfers
- Transition from “development” to “Commercial”
GMP-conform Process Development and Validation (incl. Equipment Qualification)
- Process development, manufacturing & dedicated instruments
- Current initiatives in pharmaceutical development
- Biopharmaceuticals / Biosimilars / Biologicals
- Process
- Analytical Methods
- Equipment / instruments and facility
Quality Assurance for Biopharmaceuticals
- Classical responsibilities of QA department
- Allocation of responsibilities, training of staff
- Dealing with suppliers & contractors
- The world changes: Change Management
- Shit happens: Deviation Management & CAPA
- Handling complaints & product recalls
- Paper, paper, paper: documentation works: SOPs, MBR, PQR & management report
- Surveillance of qualification & validation, calibration and maintenance
- Self inspections & auditing
Bioanalytics for Clinical Trials – Method/Process Development and Validation for Phase I – III Studies
- Definitions of terms (ICH guidelines, GCLP, GCP, GLP)
- Process development & Quality by Design
- Early clinical phases
- Late clinical phases
- Post-approval items & activities
State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 1
- Reasons for cell banking
- Where does GMP start?
- Characterization of cell banks
- Storage of cell banks
State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 2
- Overview of a typical biotech process
- Requirements on production areas, raw materials and equipment
- Specialities on biotech products
- Fill and finish
mRNA Technology – Principles, Manufacturing and Regulatory Perspective
- COVID vaccines: Viral and mRNA vaccines
- Modular principle of mRNA-based vaccines and mRNA vaccine manufacturing
- Regulatory perspective on mRNA products
- Application process for updating the MIA
- GMP challenges for new biological products
Annex 1 – Impact on the Manufacturing of Biopharmaceuticals
- Annex 1: What is the Annex 1 and why is it revised?
- Key principles of the revised Annex 1
- Impact on facility, equipment, personal, raw materials, QRM, CCS, …
- Case Study: Implementation in the daily business
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 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
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
Seminarprogramm als PDF
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