Workshop Data Integrity in Microbiology
Im Auftrag der ECA Academy

Programm

QA Oversight - environmental improvement program including aspects of the aseptic observer initiative
Audrey Meade, US – Merck/MSD

ECA Guidance for Microbiological Environmental Deviations in Non-Sterile Manufacturing
Marcel Goverde, MGP
David Roesti, Novartis
Differentiation between critical and non-critical deviations
Clear definition of actions to be taken
Needs for final approval by QA
Propositions for control levels

Q&A on Microbiological Media Challenges
Björn Breth, bioMérieux

Validation of an Alternative Microbial Enumeration Assay
Sven Deutschmann, Roche
Introduction
Requirements
Method Validation

Validation of Microbiological IPC Methods
Petra Parizek, Laves
IPC of biofermentation samples
Practical examples of validation approaches

Automation in Clinical Microbiology and/or Bacteria
Reference Standards
Isabelle Bekeredjian-Ding, Paul-Ehrlich Institut

How to handle Spreader Bacteria
Marcel Goverde, MGP
What is the spreading phenomenon?
How many CFUs are needed to spread?
How can spreaders be inhibited?

Common failure observed during autoclave and sterilization validation and routine monitoring – case studies
Walid El Azab, Steris Corporation
Discuss the top microbiological considerations when validating, requalifying and routine use of steam sterilization.
Impact of the different regulatory updates (EMA and future Annex 1 guidance) from an end-user perspective.
Common mistakes and lessons learned regarding steam sterilization autoclaves including Steam in Place (SIP) systems using case studies

New Data for MuScan Validation
Speaker, MSD

Next generation sequencing (NGS) and microbiological quality control
Elena Bolchakova, Thermo Fisher Scientific
Viral detection with massive parallel sequencing of the amplified viral genomic tags
Benefits of MPS or NGS
Possible Challenges like host cell background
Current conclusions

Workshop: Data Integrity in Microbiology

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.

Presentations
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. Antja 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

Risk Assessment Strategies
Youwen Pan, Genentech, USA