Pharmaceutical Utilities (online training)
one day digital training on pharmaceutical utilities with focus on GMP requirements, design and validation
This online training on pharmaceutical utilities starts with an introduction to the utilities in a GMP production facility: WFI, PW, black and clean steam, compressed air and other process gases.
Moving forward from the GMP regulations (US and EU) you learn what the requirements and critical design elements are, and how to perform the qualification of pharmaceutical utilities.
Part 1: introduction to pharmaceutical utilities
In the first part of this online training you learn what the most important utilities are in pharmaceutical GMP production: WFI, PW, black and clean steam, compressed air and other process gases.
Part 2: GMP requirements
In this extensive second part of the training you learn what is required according to the European and US FDA GMP guidelines and the pharmacopeia (USP, EP). You learn what the legal limits are on pharmaceutical water, steam and process gas systems.
Part 3: design considerations
In this part you learn how to design a system which can consistently produce, store and distribute a pharmaceutical utility such as WFI, PW or clean steam. Covers critical design elements and many examples, such as P&ID's of distribution networks, contact materials and instrumentation.
Part 4: commissioning & qualification
This section covers the writing of URS, commissioning and qualification up to PQ. You learn about the required validation documentation as well as the actual user requirements, and the C&Q tests needed on different pharmaceutical utilities.
Part 5: routine operations
To maintain the qualified state of a pharmaceutical utility a whole set of operational processes must be in place. In this last part of the online training you get a high-level introduction to monitoring, change control, and other key processes required by the GMP regulations.
Duration: 6 to 8 hours
Format: digital online (self-paced)
Who this training is for
- project managers
- project engineers
- QA engineers
- validation engineers
Level of experience: new to or limited experience on GMP utilities, also recommended for those with hands-on experience but new to QA or validation of utilities
Why follow this training
- provides an extensive overview of pharmaceutical utilities
- plenty of examples regarding design options and on how to perform C&Q
- online self-paced training is time and cost efficient