ECA Webinar: Data Integrity for Visual Inspection

ECA Webinar: Data Integrity for Visual Inspection

Heidelberg, Germany

Course No 17219


Costs

Non ECA Member: EUR 199,--
ECA-Member: EUR 149,--

(All prices excl. VAT)

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

Speakers

Felix Krumbein,  Roche Diagnostics

Background

The topic data integrity has been an integral part of numerous GMP inspections for several years. This involves ensuring and providing complete evidence that quality-relevant data from the manufacture or testing of a batch is correct and unadulterated. This is increasingly demanded also in connection with the data obtained in the automated visual inspection. Even if the systems work automatically, manual interventions and adjustments of inspection-relevant parameters such as lighting or mechanics may be necessary. To be able to prove with certainty in the case of a GMP inspection that the test data are nevertheless of integrity, a solid access management of the control system and an inspection-proof audit trail review concept are indispensable.

Target Group

The target group of this webinar are professionals in quality assurance, technology and production who are entrusted with the implementation or operation of automatic inspection systems or their defense during audits & inspections.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

  • General requirements for data integrity
  • Development of a suitable access control system
  • Documentation of batchwise parameter adjustments in the inspection system
  • Concepts for an inspection-proof audit trail review

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