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Online Live Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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Meet the training leader

  • Dr. Thierry Dietrich
  • Founder, Owner, Management Consultant
  • pharm@dviser, Germany
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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.

Key Topics

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

Ticket

Delegate Fee

from 1396 € Buy

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