Webinar Series on Data Integrity: Data Integrity from the view of a GMDP inspector - Webinar Recording

Webinar Series on Data Integrity: Data Integrity from the view of a GMDP inspector - Webinar Recording

Costs

ECA-Member*: EUR 199,--
Regular Fee*: EUR 249,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Franz Schönfeld, District Government of Upper Franconia, Germany

Background

Data Integrity is still a major concern with both the FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies worldwide. Data integrity is not a new topic: The principles apply to electronic and to paper-based systems. Major topics cover
  • IT Security, System and Data Integrity
  • ƒƒWritten Policiesƒ
  • Data Life Cyles
  • ƒPrinciples of ALCOA+ƒ
  • ƒƒHandling of Raw Dataƒ ƒƒReview of Dataƒ
As electronic date is widespread in Quality Control but also in Production it is getting more and more interest of GMDP inspectors.

Target Group

This webinar is addressed to employees of pharmaceutical manufacturers, authorities and suppliers with responsibility in
  • Quality assurance
  • Production
  • Quality Control
  • Inspections and Audits

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programme

Major objectives of this webinar are as follows:
  • Basic Regulatory Requirementsƒ
  • IT Security and User Management
  • Handling of Data (including Raw Data)
  • ƒData Integrityƒ
  • Examples (Production and Quality Control)
  • Inspection Findings

 

Recording from 05.10.2020
Duration of recording: about 1,5 h.

Go back

Online Training & Webinar Recordings by topic