Quality Excellence OnSite 2015 – Medical Edition at Medartis AG
The Medical Edition of our Quality Excellence OnSite events is aimed at everyone who runs or wishes to run our CAQ.Net software in the medical technology sector – especially in a validated environment. On the 8th of October, we will be spending a whole day looking into a variety of matters relevant to software validation and the usage of CAQ.Net in a regulated environment right onsite at our customer Medartis AG’s production facility in Basel (CH). Even though we will initially be looking at theoretical aspects of software validation, we will quickly switch over to the practical implementation of CAQ.Net in validated environments and hear how our customers successfully completed their validation process.
APTUS Hand fixation system for the management of fractures and arthrodeses of the phalanges and metacarpals
Validation Excellence
These best-practice examples by our customers will explain how to e.g. successfully achieve GAMP 5 validation and how part 11 compliant electronic documents and signatures can be implemented and validated.
Following a tour of the production facility at Medartis AG and a presentation on the implementation of Training Management Software in a validated environment, we will also provide detailed information on how the latest functions of CAQ AG’s software solutions can assist you in the application of the UDI-system. If you are active in the quality management field and have to do with the topic of validation, then you won’t want to miss this highly informative event.
About Medartis AG
Precision in fixation is the motto of Medartis AG. The company is a leading supplier of metal implants for the surgical management of fractures and commands extensive know-how in the development and production of high quality titanium implant systems. Whether fractures of the hand, wrist, elbow, foot, cranium, midface, or mandible: the APTUS and MODUS products along with exclusively developed technologies allow Medartis AG to sustainably improve the early functional rehabilitation of patients all around the globe.
Agenda: Quality Excellence OnSite - Medical Edition
- 09:00 am Welcome coffee/tea
- 09:30 am Opening by the host Medartis AG
- 09:45 am What is validation? An introduction
- 10:15 am Break
- 10:45 am The practical execution of GAMP 5 validations
- 11:30 am The part 11 compliant validation of electronic documents and signatures
- 12:15 pm Lunch
- 1:15 pm Tour of the production facility at Medartis AG
- 2:30 pm Application of CAQ.Net® for implementing the UDI-system
- 3:00 pm The implementation of Training Management Software in validated environments
- 3:30 pm Coffee break
- 4:00 pm Conclusion/Review
- 4:15 pm Discussions and open end of the event
The attendance fee for the Quality Excellence OnSite event at Medartis AG is € 380. In the case of CAQ AG Factory Systems customers with valid TSP status, the TSP bonus of the customer will automatically be applied to offset this fee.
Impressions
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