Compared to systems for the food or semiconductor sector, systems for the manufacture of pharmaceuticals differ in their design, but especially in terms of project management and documentation. However, the current GMP regulations define the actual requirements for these systems or components only very vaguely. The correct interpretation of these requirements can help to avoid processing errors including delays and additional costs, though.
Based on the GMP requirements, this webinar will present technical solutions for the various applications. It will show how the vaguely defined requirements for the design of systems and components, which are used for the production of pharmaceuticals, have to be concretely understood. Significant innovations, e.g. with regard to conducting qualifications, will also be discussed.
Target Group
This webinar addresses staff in plant construction, planning (engineering service providers), production and technology in medicinal products and active ingredients manufacture as well as quality assurance staff dealing with GMP & FDA-compliant projects for the construction or conversion of systems.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
As a participant of this webinar you will get insight into the current technological status and upcoming developments in engineering & construction of plants for pharmaceutical or biopharmaceutical applications.
Current GMP regulations for plant construction
Practical GMP-/FDA requirements for design of plants
Surfaces: microbiological & physical requirements
Open and closed process design
FDA compliant lubricants and sealing material
Construction materials: corrosion, certificates and clean room suitability
Cleanability of equipment and the avoidance of dead legs
Special requirements for automatization (CFR Part 11 and GAMP5)
Current changes to the qualification process
Recording from 06.07.2020 Duration of recording: about 1.5 h.
Testimonials