Puritan Enviromax and ESK for Surface Sampling

Lab Data Integrity, Meeting FDA and EU Concerns - Berlin, Germany

2017, December 5 - 7 @ 09:00 - 17:00

Pharmaceutical » Seminar

Part 1: Establishing the Controls for Ensuring Laboratory Data Integrity 5-6 December 2017, Berlin, Germany
Course 1 focuses on three types of record that can be found in analytical laboratories working to GMP: paper, hybrid computerized system and electronic workflows with electronic signatures. Through presentations, workshops and discussions attendees are taken through the process from analysis to generation of results to understand data integrity issues.

Part 2: Self Inspections and Audits to Confirm Effective Data Integrity Controls 6-7 December 2017, Berlin, Germany
Course 2 takes the principles from the earlier course and develops them to enable attendees to be able to conduct effective internal audits or self-inspections of either hybrid or electronic systems in compliance with EU GMP Chapter 9. This is achieved mainly via a series of interlinked workshops with a few presentations. This course will focus only on hybrid and electronic systems.

For more details and regsitration visit: www.gmp-compliance.org




Concept Heidelberg
Phone: +[49] 62 21/84 44 0
Email: info@concept-heidelberg.de
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