Markus Multhauf, Senior Consultant GMP-Engineering
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.
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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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