Maximum visualization of contamination
At this year's event, the COWA cleanroom experts will provide insights into the training methods where staff can gain their own experience of contamination control.
Maximum visualization of contamination
At this year's event, the COWA cleanroom experts will provide insights into the training methods where staff can gain their own experience of contamination control.
Regulations for pharmaceutical water - What MUST, SHOULD and CAN?
Monographs, GMP, EMA, WHO, ICH, PIC/S, ISPE guidelines, DIN/ISO standards etc. pp. and so on. - all of which have been heard and possibly read and applied before; but which guidelines and standards are really legally binding and must be complied with and which are "only" guidelines, but should still be complied with? Using the example of pharmaceutical water, this presentation aims to shed some light on the [...]
Increasing process yield and safety in cleanrooms
The topic of this presentation is the influence of Airborne Molecular Contamination (AMC) on process safety and yield. Cleanrooms are designed to maximize process flow and yield, while the tight conditions of the process window and the serviceability of the process equipment must be maintained. With strict cost and space optimization, AMC interferes with cleanroom design and production by reducing yield. Due to the [...]
Discussion - Pharmaceutical water: Stimulating new paths
The discussion is inspired by the approaches of the presentation by Thomas Herbelssheimer, Roche, ("Reuse of pharmaceutical water"). But what do the audience and the experts think about where the journey towards more sustainable plants and their operation could or should go? What paths can be taken without running into regulatory problems? What needs to be done by the authorities [...]?
What happens when it happens....Disaster Recovery
The rapid digitalization of the pharmaceutical industry is leading to an increased dependency on IT systems and data. The smooth execution of business processes and decision making is essential to the uninterrupted availability of these resources to ensure compliance and efficiency. Criminal activity, political instability and environmental risks underline the need for well thought-out disaster recovery and business continuity planning. Measures such as regular data backups, redundant [...]
Can pharmaceutical water be reused?
Sustainability will be a key issue for us in the coming years. Like many others, Roche Diagnostics has thought about how expensive CIP final rinse water can be reused after it has been used in the process. The presentation provides details and suggestions for replication.
Validation strategies for computer-aided systems
- The role of critical thinking in optimizing CSV strategies - "Records over Documents" and the use of tools in validation - Agile software development in a regulated environment This presentation will provide an overview of modern strategies for validating computer-aided systems, taking into account digitization and in line with GAMP 5. The aim is [...]
Discussion round - CU projects
We will look together at the "do's and don't's" in projects in a panel discussion in which the lessons learned from these projects and possible developments in project management over the next few years will be openly discussed. Topics such as data management, PoU management and AI will be highlighted.
Critical Utilities projects: Exciting and unique
This presentation is dedicated to the fascinating and unique aspects of high-purity media projects. We will address this topic in several steps: 1. content of high-purity media projects: - high-purity media that the ISPE Group deals with - project types and execution scenarios that are typical for the field of high-purity media - project phases that are crucial in [...]