Data Integrity in Pharma & Biotech

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

online live

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

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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

Registration

Training ticket

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Online Live Stream
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