Dr Harald Stahl
GEA
Referent:innen
Hintergrund
Exposure to active pharmaceutical ingredients must be kept within acceptable limits. The protection of employees must be achieved primarily by technical measures and not through personal protective equipment. Several containment solutions like glove boxes, islolators, special valves and transfer ports are available. This equipment has to fit to the surrounding, the product requirements and the organisational circumstances. Therefore detailed planning is necessary.
But GMP also has requirements for contamination or the avoidance of contamination / cross contamination as far as possible (see chapters 3 (Premises & Equipment) and 5 (Production) of the EU GMP Guidelines. By introducing the PDE concept (Permitted Daily Exposure) by the European Medicines Agency, occupational medicine and GMP requirements are now based on the same scientific basis, namely on the question: how much exposure is uncritical for a person (whether patient or employee)? This important question has to be answered for both, dedicated and multipurpose equipment.
But GMP also has requirements for contamination or the avoidance of contamination / cross contamination as far as possible (see chapters 3 (Premises & Equipment) and 5 (Production) of the EU GMP Guidelines. By introducing the PDE concept (Permitted Daily Exposure) by the European Medicines Agency, occupational medicine and GMP requirements are now based on the same scientific basis, namely on the question: how much exposure is uncritical for a person (whether patient or employee)? This important question has to be answered for both, dedicated and multipurpose equipment.
Zielgruppe
This Webinar aims at persons from production, engineering and quality, responsible for
- Occupational safety
- Cleaning concepts and contamination prevention
- Design of new manufacturing areas
as well as engineering and plant-construction companies working in containment projects.
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.
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.
Programm
The aim of this webinar is to make you a competent partner for dealing with highly active substances - both from an occupational safety and a GMP ((avoidance of cross-contamination) point of view:
- Exposure and how to calculate
- Equipment and containment concepts
- Closed product handling
- Sampling
- Material transfer
- The PDE/ADE concept: how much contamination is allowed?
- Avoiding of cross contamination
- Air born contamination
- Contamination of surfaces
- Verification of the tightness of a containemt system
Recording from 06.07.2020
Duration of recording: about 1.5 h.
Duration of recording: about 1.5 h.
| ECA-Member*: | € 199,- |
| Regular Fee*: | € 249,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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