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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

Given the global nature, digitalization & ever increasing complexity of today’s drug manufacturing chains, regulatory bodies are putting the integrity of the data under ever greater scrutiny and raising the bar around what’s expected when it comes to data integrity and product quality.

Leading pharmaceutical and biotech companies are re-assessing the processes and digital tools (incl. information systems) they use to collect, handle and organize QC and manufacturing data.

This practical course provides an in-depth understanding of data integrity in a GMP context and brings clarifications on regulatory requirements as well as the examples of common data integrity issues reported by FDA and EU inspections. It will focus as well on a risk-based approach to data integrity, data governance systems as well as on audit strategies.

Key topics

Data perspective vs. process and system perspective

Data migration

Data quality and data integrity in the cloud

E-signatures and data integrity

Data integrity issues in automation

Audit trail

Data integrity auditing

Benefits of attending

Understand the interpretation of relevant regulation and guidelines

Gain examples of common data integrity issues reported by FDA & EU from their inspections

Learn about ALCOA+ criteria & further data quality characteristics

Gain insights into a risk-based approach to data integrity

Practice risk assessments & define mitigation measures

How does the validation of computerised systems apply to data integrity controls

Learn how to overcome challenges of hybrid systems and cloud computing

Reveal the structure, roles & responsibilities in a data governance system

Understand the data lifecycle

Discover identity & authorization management when using e-signatures

Practice how to overcome data integrity issues related to e-signatures

Gain practical hints on how to deal with data integrity issues related to automation in an GMP area

Understand regulatory requirements & expectations on audit trail review

Learn about what audit trail data should be reviewed & with what periodicity

Discover data integrity audit types, strategies and approaches

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from 1396 € Buy

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