Dr Michael Drechsler
Bayer Consumer Care
Referierende
Prof. Dr. Miriam Pein-Hackelbusch
University of Applied Sciences and Arts Ostwestfalen Lippe
Dr Claude Oelschlaeger
Karlsruhe Institute of Technology
Dr Michael Czieborowski
BAV Institut für Hygiene und Qualitätssicherung
Highlights
- GMP aspects relevant to semisolids
- Manufacturing & filling of semisolids
- Microbiological requirements
- Manufacturing & filling of semisolids
- Microbiological requirements
Zielgruppe
This training aims at specialists and executives in research, development, production, quality control and quality assurance involved in the manufacturing, packaging, testing, release and authorization of pharmaceutical semisolids and cosmetic preparations.
Zielsetzung
This training aims at explaining the pharmaceutical, biopharmaceutical and technological aspects of various semi-solid dosage forms for topical use.
Formulation concepts (including the use of emulsifiers and colloidal carrier systems), GMP aspects and the industrial manufacture/ filling of semi-solid formulations are clearly illustrated. The rheological characterization as well as microbiological and stability testing will be covered.
Formulation concepts (including the use of emulsifiers and colloidal carrier systems), GMP aspects and the industrial manufacture/ filling of semi-solid formulations are clearly illustrated. The rheological characterization as well as microbiological and stability testing will be covered.
Programm
Relevant Semisolids
- Classification according to Ph. Eur.
- Dispersions and phases
- Examples of relevant excipients
- What about nanocarriers?
Industrial Manufacturing of Semisolids – General Aspects
- GMP
- Validation
- Scale-up
- Risk assessment
Manufacturing of Semisolids – Practical Aspects
- Equipment
- Process
- IPC
- CIP/SIP
The Application and Use of Excipients – Insights and Challenges
- Influence of excipient selection on performance
- Emulsifiers/surfactants in formulations
- Chemical and physical insights
- Excipient performance / functionality related characteristics
Filling of Semisolids
- Storage Containers
- Packaging Material - tubes
- Filling machine & Process
- IPC
Rheology of Emulsions
- Basic phenomena
- Experimental characterization techniques
- Rheology and composition of emulsions and dispersions
- Technical application examples
Biopharmaceutical Aspects of Semisolids
- EMA Guideline on quality and equivalence of topical products
- In vitro drug release
- Drug penetration into the human skin
- The interplay between vehicle and drug
Microbiological Tests and Stability
- Pharmacopoeial requirements
- Acceptance level & Interpretation of test results
- Efficacy of antimicrobial preservation
- Requirements according to Ph. Eur. and USP
- Aspects to consider for stability testing
Weitere Informationen
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 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
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.
Contacts
Questions regarding content:
Dr Gerhard Becker, +49 6221 84 44-65, becker@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
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 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
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.
Contacts
Questions regarding content:
Dr Gerhard Becker, +49 6221 84 44-65, becker@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 30 June 2026, 9:00-16:45 h
Wed, 1 July 2026, 9:00-12:45 h
Wed, 1 July 2026, 9:00-12:45 h
Teilnahmegebühr
| 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
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
