events
  • Pharma
  • Training Courses | Online Live Stream

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

  • 3 – 5 December 2024
  • Online Live Stream | 9:00 CET – 15:30 CET
Days
Hours
Minutes
Seconds

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

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

download brochure
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

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 in a workshop
  • Practice system periodic review activities in a workshop
  • Get insights into key aspects of qualifying cloud service providers (CSP)
  • 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
  • Case study on implementation of a SaaS ERP system in a GxP context
  • Case study on implementation of a PaaS based WMS system in a GDP 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
Previous
Next
Registration

Training ticket

Online Live Stream
FROM
1496€
BUY TICKET

Contact us

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

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

Name
Job
Company
Bio
Name
Description