Become a member of the ISPE
Discuss with us; ask your questions and get testimonials from our team
Electronic Production Records
- Electronic production records - Relevant data - Data acquisition / data input - Data flow (process view) - Review by exception
Become a member of the ISPE
Discuss with us; ask your questions and get testimonials from our team
Become a member of the ISPE
Discuss with us; ask your questions and get testimonials from our team
WFI - Reference project: Sustainability - thought through to the end
The presentation will introduce a new MWFI system for a manufacturer of sterile primary packaging. The special features are: - Membrane-based WFI generator with full redundancy - Total water yield (WFI/feed water) > 85% - Direct supply of cold and hot consumers without a tank - Extensive reduction in steam requirement thanks to heat recovery - Improved water quality in terms of contamination potential, particle load, PFAS and non-condensable gases - Measurement [...]
Vulnerability Management & Patch Management
In IT environments, the general principle is to apply security patches at an early stage in order to minimize the potential for attacks on your own infrastructure and prevent risks and possible damage. This has proven to be an effective and important component of "cyber hygiene". Why this is not (always) the best approach in OT environments and how risk-based vulnerability management can be used instead as a pragmatic approach to [...]
(AI) enablement of existing GxP production processes
(AI) enablement of existing GxP production processes through low-code/no-code platforms
GAMP Community of Practice - Update
I. GAMP Community of Practice - Update II. Smart validation through clever integration of risk & knowledge management - How can QA be strategically aligned to manage knowledge and risks in a targeted manner, ensure compliance and guarantee quality? - How can the flood of documents be reduced in order to achieve efficient and lean validation without bureaucratic hurdles?
WFI design - what to do when the Chinese Pharmacopoeia ChP changes?
Imagine you are planning a new WFI system and need to meet ChP requirements, but a change to membrane generation and cold storage is foreseeable. The presentation shows possibilities for different situations: new system already under construction, new system in the design phase, or future installation planned.
The biology of ageing - and what you can do about it.
Medicine is developing rapidly. The sequencing of the human genome has significantly accelerated our understanding of the mechanisms of ageing. Strategies for a long, healthy life are becoming increasingly feasible. The key lies in the analysis of genetic predispositions, individual prevention and the reduction of vascular risk factors. Prof. Dr. Volker Limmroth, one of the leading [...]