Development process following GAMP5 & the SSSE Annual General Meeting 2017

 
Title:
Development process following GAMP5 & the SSSE Annual General Meeting 2017
 
Presenter(s):
Urs Müller is Head of the Business Unit System Quality Engineering at konplan systemhaus ag, currently leading a team of experts focused on classical software testing, software development for Medical Devices and Q&V activities in the production of medical devices or pharmaceutical companies.
 
Ozan Okutan is Senior Quality Engineer at konplan systemhaus ag. He has worked in several projects and companies dealing with different aspects in computerized system validation. His experience includes validation of document management systems, change management handling, facility verification and Track & Trace systems for the pharmaceutical industry.
 
Content:
GAMP stands for Good Automated Manufacturing Practice. The lecture will give an overview of the GAMP 5 approach, an industry guideline widely used in the medical device and pharmaceutical industry. In short, GAMP 5 defines a lifecycle model for computerized systems used in medical device and pharmaceuticals production. The lifecycle starts with the need to buy or build a computerized system and ends with the retirement of it. The range of systems amongst others includes simple of the shelf software products, ERP solutions, excel sheets or PLC driven facilities as well as the inventory and classification processes of the computerized systems.
 
After the lecture the SSSE will have the Annual General Meeting 2017.
 
Contact:
For any information contact us via E-mail.
 
Location: NEW! Hochschule Luzern, Campus Zug-Rotkreuz, Suurstoffi 12, 6343 Rotkreuz
 
Programme: Tuesday, December 5th 
17.30 - Arrival
18.00 - Lecture and Q&A on GAMP5 
18.45 - Annual General Meeting 2017 
19.15 - Networking & Aperitif 
 
Flyer: Download the programme hereafter.
 
Attendance: The event is free, registration by booking with account for all SSSE events or by E-mail.
 
Recapitulation: refer to the News after the event.

 

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