. European Microbiology Conference 2018 .

Workshop “Data Integrity in Microbiology”

on 24 April 2018

Objectives

This workshop will cover the regulatory requirements and present
approaches and practical experiences on the implementation of data integrity strategies in microbiological laboratories. It will provide you the possibility to discuss the challenges of the ongoing automation of
methods and processes in relation to the increasing requirements of data integrity.
Background

Even Data Integrity is one of the basic GMP principles. Multiple Data Integrity issues were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue to be the focus of many GMP inspections.

As a consequence, international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe the regulatory expectations of Data Integrity.

Even though the guidelines are not intended to impose additional regulatory burden upon the regulated companies, a lot of uncertainty predominates the pharmaceutical industry about how to implement these requirements into the daily business. 

Microbiological laboratories are influenced by these developments,
as well.

Target Audience

All persons which will be involved in collecting, analysing and trending data in microbiological laboratories and will be challenged by the lab data integrity requirements. Additionally, all persons from QC and QA who have to judge these data for risk evaluation or release questions.

Moderators

Dr. Sven M. Deutschmann, Roche Diagnostics GmbH
Chairman of  ECAs Pharmaceutical Microbiology Working Group

Programme

Requirements on Data Integrity in Laboratory

Gerald Kindermann, F. Hoffmann-La Roche, Switzerland

 

Life cycle approach for qualification of computerized systems in microbiological testing

Dr. Antje Motzek, Labor L+S AG, Germany

Data Integrity – Challenges in Microbiology

Di Morris, GSK, United Kingdom

Importance of Data Integrity when Testing for Endotoxin

Robert Porzio, Lonza, USA

Implementation of contemporaneous verification for visual readouts in QC microbiological tests using a risk based approach

Youwen Pan, Genentech, USA

  • Characteristics of non-automatic QC microbiological tests in terms of data integrity (DI)
  • Utilization of risk assessment to identify the microbial tests requiring contemporaneous verification
  • Risk mitigation strategy on DI of microbiological tests