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Computerized Systems Validation, Data Integrity & Cloud Computing in Pharma & Biotech

  • 14 - 16 February 2024
  • Online Live Stream | 9:00 CET – 15:30 CET
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Computerized Systems Validation, Data Integrity & Cloud Computing in Pharma & Biotech

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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 cloud-based systems in GxP regulated context, and how CSV relates to data integrity assurance. This course is meant to be an advanced course on selected modern CSV methods with special consideration of aspects playing into today’s omnipresent challenges around data integrity and cloud services.

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

Brochure

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

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Computerized Systems Validation online live training by Fleming_Agenda Cover
Computerized Systems Validation online live training by Fleming_Agenda Cover
Computerized Systems Validation online live training by Fleming_Agenda Cover
key training

Topics

CSV considerations around data integrity and cloud-based systems

Inspection trends around CSV and data integrity

Qualification of Cloud Service Providers

Service Level & Quality Assurance Agreements

Requirements for e-signatures/biometric signatures

Taking a data perspective

Data requirements for validation

Data migration and interfaces

Physical & logical security in a GxP cloud system

System periodic review

System overview document

IT incident & change management in a GXP context

Implementation of a SaaS ERP System in a GxP Context

Benefits of attending

  • Learn how CSV can support data integrity
  • Gain insight into the recent inspection trends around CSV and data integrity
  • Reveal FDA and EU requirements for e-signatures/biometric signatures
  • Understand what a data perspective means
  • Discuss data requirements for cloud services in a workshop
  • Practice system periodic review activities in a workshop
  • Get insights into key aspects & processes to consider in qualification of cloud service providers
  • Gain tips for data migration & interfaces
  • Master regulatory compliance of outsourced processes
  • Leverage COTS CSP specifications & CSP test documentation
  • Best practices in physical & logical access controls in GxP Cloud systems
  • Best practices in IT Incident, Problem, and Change Management in a GXP Cloud Context
  • Case study on implementation of a SaaS ERP System in a GxP Context

Testimonials

A really good course, and useful experience of knowledge exchanging, that may help to improve your own company data integrity policy.
Stefania CorrealeQC Associate, Kedrion Biopharma, Italy
The content of the course was a good oversight of the aspects related to the subject.
Alba MartínezQA Specialist, Corbion, Spain
Course based on the awareness and involvement of people on the subject matter.
Francesco MaroneValidation & Lab Services Specialist, Merck Group, Italy
The seminar provided a good opportunity for a better overview of data integrity guidelines, regulatory requirements and legislation. Also the workstation based on real case studies was a nice idea.
Konstantinos PanosQA Qualification Supervisor, Rafarm s.a, Greece
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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

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