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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
Learn more

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. Join us in Amsterdam and learn how to overcome your data integrity challenges.

Key topics

Risk assessment & mitigation measures

Data integrity in paper documents, electronic and hybrid systems

Data governance

Data perspective vs. process and system perspective

Data quality and data integrity in the cloud

E-signatures and data integrity

Excel spreadsheets and data integrity

Audit trail

Data integrity auditing

Special Features

All delegates will receive electronic
course documentation

Certificate of Attendance issued by the trainer

Hands-on case studies & practical examples

4x Workshops

Interactive learning approaches

Survey of participants challenges

Key Topics

•  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

Key Takeaways

• Discover identity & authorization management when using e-signatures

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

• Explore the risks of using excel spreadsheets & how to tackle the data integrity issues

• 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

Join us in Amsterdam

Amsterdam is the capital, the principal commercial and financial center of the Netherlands. To the scores of tourists who visit each year, Amsterdam is known for its historical attractions, for its collections of great art, and for the distinctive color and flavor of its old sections, which have been so well preserved.

Ticket

Delegate Fee

from 2196 € Buy

Online Live Stream

from 1296 € Buy

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