Validation of computerized systems according to GAMP5 2nd edition

• Understand and assimilate the validation process applied to computerized and automated systems according to the new version of the GAMP5 methodology
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• Assimilate and apply GAMP 5, FDA approaches and “Data Integrity” requirements
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• Assimilate and apply the “Risk Analysis” approach to comply with 21CFR part 11, Annex 11, and the new Data Integrity guidelines.
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• Know how to define the activities and the just necessary effort to validate each automated and computerized system by assimilating the risk approach of validation
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• Know how to write protocols and test sheets in an optimal way by applying the new CSA concepts “FDA CSV_for_Production_and_Quality_Systems”

• Course based on the ISPE guidelines, GAMP5 2nd edition, the Data Integrity guidelines, the CSA guidance (draft) FDA CSV_for_Production_and_Quality_Systems
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• Presentation and delivery of a complete course material

• All persons concerned with the validation of information and automation systems (ERP, GPAO, LIMS, LIMS, ELN, SCSE, WMS, MES, PLCs...): Information System and Automation Project Managers (functional and technical), User Project Managers, User Project Managers, Validation Managers, Validation Managers, Representatives of the Quality Assurance Department, integrators, editors, hosts...
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• Prerequisites: it is necessary to know the GAMP 5 first version

First day

1. Presentation of the evolutions of the GAMP5 2nd edition
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2. The modern validation process:

• Planning: Validation Plan, Criticality Analysis, Supplier Audits
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• Critical thinking approach (Risk Analysis) and GAMP categories
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• IT infrastructure and application management in SaaS mode
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• Requirements specifications
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• Design review & traceability
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• Testing: contribution of the new FDA guidance “CSV for production & quality systems” for optimized testing
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• Agile development
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• Management of software tools
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• Artificial intelligence and machine learning
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• Maintenance of the validated state: periodic reviews, operating procedures, change control and backup/restore procedures...

Second day

• Focus on SaaS systems
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• Maintenance of the validated state: periodic reviews, operating procedures, change control and backup/restore procedures...
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• In-session exercise
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• Feedback on ad-hoc points based on shared experiences and/or
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• Design of key validation documents: presentation and design of an example of: Design review, Installation, Operational and Performance Test Protocols.
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• Comprehension assessment quiz and joint debriefing.