Artificial Intelligence & Cloud: Validation and Data Integrity in a BioPharma GxP Environment

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Artificial Intelligence & Cloud: Validation and Data Integrity in a BioPharma GxP Environment

online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

This course is a compilation of topics representing recent challenges related to CSV of AI or cloud-based systems in a GxP regulated context, and how CSV relates to data integrity. This course is meant to be an advanced course on selected modern CSV methods with special consideration of aspects playing into today’s challenges around data integrity and modern technologies such as AI and cloud services.

meet the training leaders
Dr. Thierry Dietrich
Founder, Owner, Management Consultant
pharm@dviser, Germany
Margit Jekle / Guest Speaker
Professor
SRH Fernhochschule – The Mobile University, Germany
Sinan Sahin / Guest Speaker
Computer Validation Manager, CSV-Consultant
VQC Consulting GmbH, Germany
training

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Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Artificial Intelligence & Cloud online live training organized by Fleming_Agenda Cover
Artificial Intelligence & Cloud online live training organized by Fleming_Agenda Cover
Artificial Intelligence & Cloud online live training organized by Fleming_Agenda Cover
key training

Topics

CSV considerations around data integrity

How to validate an AI based system

Validation of a cloud-based system

Inspection trends around CSV and data integrity

Qualification of cloud service providers (CSP)

Service level agreements (SLA) & quality assurance agreements (QAA)

Requirements for e-signatures/biometric signatures

Data requirements for validation, data migration & interfaces

Physical & logical security in a GxP cloud system

System periodic review

IT incident & change management in a GxP context

Implementation of a SaaS ERP system in a GxP context

Implementation of a PaaS based WMS system in a GDP context

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Testimonials

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