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When
When:

February 26, 15:00 - 18:00 (UTC+2)

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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: To participate in this seminar, please fill in the form below and press the Submit button. A confirmation email will be sent to the email address you register with.

Seminar on data integrity and FDA Title 21 CFR Part 11
Yes, I would lilke to attend this seminar on February 26 2019!
Topics of special interest to our company:

 

Agenda:
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.

Welcome!

Event details
When:
February 26, 15:00 - 18:00
Where:
Smedsgränd 3
Uppsala, 75320 Sweden
Website:
Seminar on Data integrity & Practical FDA Title 21 CFR Part 11
Venue
Data Ductus
 
Smedsgränd 3
Uppsala, 75320 Sweden

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Website:
www.dataductus.se