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Data Integrity in Pharma & Biotech

  • 24. - 26. November 2021
  • Online Live Stream | 14:00 – 18:00 CET
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Data Integrity in Pharma & Biotech

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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

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.

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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Data Integrity in Pharma & Biotech Training Course | Fleming
Data Integrity in Pharma & Biotech Training Course | Fleming
Data Integrity in Pharma & Biotech Training Course | Fleming
key training

Topics

Data integrity in a GMP context

Regulatory framework & guidelines

Risk assessment & mitigation measures

Data governance

Data integrity in paper documents, electronic and hybrid systems

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

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
Registration

Training ticket

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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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