Data integrity & Practical FDA Title 21 CFR Part 11
Data Ductus offers a seminar, free of charge, in Uppsala on the 26th of February. The seminar will be held in Swedish unless there are English speaking participants.
The pharmaceutical and medical device industry is experiencing a digital transformation driven by the need to enable efficient data sharing and automation in its manufacturing and distribution practices – typically by means of GxP systems. Ensuring regulatory compliance in this transformation is often challenging. There are practical, procedural as well as technical aspects to consider.
Our seminar begins with a crash course on the impact that especially Title 21 CFR Part 11 of the US Code of Federal regulations has on the industry, its requirements on data integrity and corresponding procedural and technical implications. We highlight some common difficulties and discuss best practices for dealing with them.
Event registration: This event has passed.
15.00-15.15 – Introduction
15.15-16.15 – Title 21 CFR Part 11 presentation and analysis of its impact
16.15-16.30 – Coffee break
16.30-16.45 – Introducing focus areas for drill-down discussions
17.00-18.00 – Seminar discussions on specific themes
At least two of the following themes (depending on participants’ interests) will be discussed in more detail during group discussions:
- When does ER/ES (part 11) apply?
- System Validation – 11.10(a) (Limited and authorized system access)
- User-Independent Computer-Generated Time-Stamped Audit Trails – 11.10(e)
- Accurate and Complete Copies §11.10(c)
- Record and Signature linking – §11.70
For further questions please email eventsmanager (at) dataductus.se.