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Computerized Systems Validation & Data Integrity in Pharma & Biotech

  • 9 - 10 March 2023
  • Online Live Stream | Vienna, Austria | NH Danube City | 9:00 CET – 17:00 CET
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Online Live Stream

Computerized Systems Validation & Data Integrity in Pharma & Biotech

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Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer
Case studies from the trainer's experience

Certificate of completion issued by the trainer

Comprehensive course documentation
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, 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.

meet the training leader
Thierry Dietrich | Fleming
Linkedin
Dr. Thierry Dietrich
Founder, Owner, Management Consultant
pharm@dviser, Germany
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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 and Data Integrity in Pharma and Biotech online live training Fleming Agenda Cover
Computerized Systems Validation and Data Integrity in Pharma and Biotech online live training Fleming Agenda Cover
Computerized Systems Validation and Data Integrity in Pharma and Biotech online live training Fleming Agenda Cover
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Topics

CSV considerations around data integrity

Auditing GXP computer systems

Inspection trends around CSV and data integrity

Requirements for e-signatures/biometric signatures

Shifting to a data perspective

Data requirements for validation

Data migration and interfaces

Verification & testing methods

Iterative prototyping & agile methods

Physical & logical security

System overview document

IT incident & change management in a GXP context

Benefits of attending

  • Learn how CSV can support data integrity
  • Discuss & understand auditing GXP computer systems
  • Gain insight into the recent inspection trends around CSV and data integrity
  • Reveal FDA and EU requirements for e-signatures/biometric signatures
  • Understand what does a shift towards a data perspective mean
  • Discuss data requirements for validation in a workshop
  • Reveal verification and testing methods, as well as agile methods
  • Understand physical and logical security
  • Practice system periodic review activities in a workshop
  • Get tips for handling IT incidents & IT related unplanned events

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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Training ticket

Online Live Stream
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1596€
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Venue

NH Danube City 

Wagramer Str. 21,
1220 Wien, Austria
Phone: +43 1 260200

NH Danube City
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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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