Train your staff with the latest markets standards
We offer training sessions you can follow either with your coworkers or with people from other companies, depending on your needs. Like all the services we provide, our training sessions are strictly based on the GAMP(R) methods and the ISPE(R) guidelines. PHARMASYS is a certified trainer under licence n° 11 91 0612091
Discover our training packages :
Computerized systems validation GAMP5 approach (2 days)
Understand and assimilate the validation guidelines applied to computerized and automated systems according to the validation methodology GAMP5 and new Data Integrity requirements…
Data integrity and applied risk analysis of computerized systems (2 days)
Acquire a concrete, robust, structured and repeatable method of GxP risk analysis of computerized systems in accordance with Data Integrity requirements…
Data integrity of computerized systems (1 day)
Knowing how to independently carry out a GxP risk analysis on all types of systems and articulated around regulatory requirements (GMP, Part 11, ICH Q9, Part 820, Data Integrity)…
Maintenance of validated state of GxP systems (1 day)
Understand and assimilate the process of maintaining the validated GxP state of computerized and automated systems according to the GAMP5 approach…
Medical Device Software GxP Compliance (1 day)
Know and understand the applicable requirements for GxP regulatory compliance of computerized medical devices and for computerized systems participating in the Quality of medical devices…
Validation of Excel applications (1 day)
Know how to assess the conformity of an Excel application
Understand how to specify and document an Excel application…
Data Integrity awareness and validation of Computerized Systems (2 to 4 hours)
Understand the validation of computerized systems
Understand the need (regulatory requirements) and the usefulness (Good Practices) of IS validation…
Electronic archiving (1 day)
Know the regulations and standards applicable for healthcare companies in the field of electronic archiving
Define the concepts of electronic archiving, storage and backup…
Carreers
As part of our development, we are strengthening our teams.