Dr Harald Stahl
Romaco
Referierende
Dr Josef Hofer
exdra
Sue Mann
Sue Mann Consultancy
Dr Georg Böck
Boehringer Ingelheim Pharma
Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr Janine Fischer
Roche Diagnostics
Highlights
- Pharmaceutical Knowledge explained for Non-Pharmacists
- Comprehensive Overview from Drug Development to Release
- Understanding Interdependencies, Processes, Responsibilities
Zielgruppe
This seminar is designed for non-pharmacists working for or with pharmaceutical companies. It is also intended for individuals working in the pharmaceutical industry who are active in fields adjacent to manufacturing, including:
- Employees in engineering, sales, logistics, business development, etc.
- Plant manufacturers, planners, and service providers
- Prospective heads of production and quality assurance without a pharmaceutical background
- Anyone seeking a comprehensive overview of pharmaceutical knowledge
Zielsetzung
This live online training provides a comprehensive overview of pharmaceutical knowledge, from drug development to release, making these topics understandable even for non-pharmacists.
The seminar helps participants to understand the interdependencies, responsibilities, and decision-making processes across the pharmaceutical manufacturing chain, addressing the following questions:
The seminar helps participants to understand the interdependencies, responsibilities, and decision-making processes across the pharmaceutical manufacturing chain, addressing the following questions:
- Where does GMP begin?
- How does the pharmaceutical quality assurance system work?
- What does a marketing authorization contain, and how does this affect production?
- How are tablets and other dosage forms manufactured?
- What are the critical process parameters and equipment components?
- How do the different dosage forms work?
- Who is responsible for what and who makes which decisions?
Programm
The Pharmaceutical Quality System
- Quality terms and interpretations
- Structural and procedural organisation in pharmaceutical companies
- Industrial pharmacy regulations and the role of pharmacopoeias
- GMP-relevant regulatory areas
- Document management
Regulatory Affairs
- The authorisation system
- Change procedures
- GMP monitoring
Pharmaceutical Dosage Forms & Actions of Drugs
- Different dosage forms and their applications
- Resorption, distribution, biotransformation
- Kinetics and mechanisms of action
- Side effects and interactions
- Clinical trials
- From active ingredient to finished medicinal product
Drug Development
- Fundamentals of active ingredient research
- Determination of dosage form
- Pre-formulation
- Galenic development
- Quality by Design
- Transfer
Solid Dosage Forms
- Fundamentals of manufacturing: granulation and tableting
- Critical process parameters
- Technical operating principles
- Requirements for machinery and equipment
- Handling of highly potent substances
- Practical examples
Machine Packaging of Pharmaceuticals
- What different technologies are available for blister packaging of solid dosage forms?
- Which dosage forms are particularly suitable or unsuitable for blister packaging?
- Which primary and secondary packaging materials can be used and how can they be printed?
- What deviations and risks are there in packaging processes?
- How can product quality be ensured through a GMP-compliant process?
- What are the special features of pharmaceutical packaging?
Microbiological Contamination - Microbiological Quality Control
- Definitions: Colony count (CFU), sterility, pyrogenicity/endotoxins, LAL, SAL, disinfection
- The five M factors of contamination
- Material: Raw materials, packaging materials, water
- Methods: Decontamination, cleaning, disinfection, Sterilisation
- Machines (devices and equipment)
- Medium (Environment): production environment / zone concepts /isolator / RABS / LF / environmental controls
- Man (Personnel): health monitoring / clothing, behaviour, training - Significance of microbial contamination
- Microbiological testing methods and pharmacopoeia requirements
Aseptic Manufacturing of Sterile Pharmaceutical Dosage Forms
- Requirements for aseptic bulk production
- Sterile filtration and media fills
- Process sequences for the production of prefilled syringes, liquid vials, lyophilisates
- Container Closure Integrity Testing (CCIT) of sterile products
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
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 € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 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:
Ms Sarah Schmidt (Operations Director), +49 6221 84 44-16, s.schmidt@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald (Organisation Manager), +49 6221 84 44-51, strohwald@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 23 Sept 2026, 9:00 – 16:45 h
Thu, 24 Sept 2026, 8:30 – 16:45 h
Thu, 24 Sept 2026, 8:30 – 16:45 h
All times mentioned are CEST
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
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
