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.
Data perspective vs. process and system perspective
Data quality and data integrity in the cloud
E-signatures and data integrity
Data integrity issues in automation
Data integrity auditing