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
Objectives
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:
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?
Programme
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
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.
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 € 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.
Testimonials
