CSV according to GAMP 5 Second Edition and the CSA guidance

Service Description

The aim is to understand and master the computerized system validation approach according to the GAMP 5 Second Edition methodology and the FDA's CSA (Computer Software Assurance) approach. Topics covered: • Objectives and benefits of computerized system validation for your company • Applicable regulatory and normative requirements • The main validation phases / Computerized system lifecycle approach • What the second edition of GAMP 5 brings • What CSA (Computer Software Assurance) brings • Critical thinking approach • Defining validation activities and scaling the effort according to risk • What CSA (Computer Software Assurance) brings to testing activities • Agile development and its impact on validation • Data integrity requirements related to computerized system validation • How to leverage supplier activities • Maintaining the validated state By the end of this training, we hope your teams will be able to: • Know what GAMP 5 Second Edition and CSA bring to current practices • Define validation activities and scale the effort according to risk • Use risk analyses to define and optimize the testing effort.