GAMP 5 TRAINING – JANUARY 2021

In a perspective to always be efficient and to excel, Pharmasys organizes training sessions on validation & Data integrity of computerized systems according to the GAMP5 methodology for our new colleagues.

The objectives of this training :

• Understand and assimilate the validation guidelines applied to computerized and automated systems according to the validation methodology GAMP5 and new Data Integrity requirements
• Assimilate and apply GAMP5 concepts, ASTM E2500 approach and new Data Integrity main concepts
• Assimilate and apply the 21CFR part 11 and new Annex 11 “risk analysis” approach.
• Assimilate a “modular” approach to Validation in order to be able to define the activities and effort required to validate each automated and computerized system
• Assimilate the writing of the protocols and test sheets

We would like to thank our new recruits for their commitment, dynamism and motivation.