Development, Manufacture & Control of Dermatopharmaceutics and Cosmetics
30 June / 1 July 2026
Course No. 22754
Speakers
Dr Michael Drechsler
Bayer Consumer Care
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
Target Group
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.
Objectives
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.
Programme
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
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 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.
Testimonials
