Modern Microbiology Laboratory - Live Online Training Mastering the challenges of classic and modern microbiological methods

Modern Microbiology Laboratory - Live Online Training

Course No 20288

This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager". Learn more.

All times mentioned are CET.


This training/webinar cannot be booked. To find alternative dates for this training/webinar or similar events please see the events list by topic.

For many training courses and webinars, there are also recordings you can order and watch any time. You can find these recordings in a list sorted by topic.

Or simply send us your inquiry by using the following contact form.

* 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:


Sven M. Deutschmann, Roche Diagnostics, Germany
Sabrina Schmidt, Novartis Pharma Stein, Switzerland
Dr Holger Kavermann, Roche Diagnostics, Germany
Arjan Langen, GE Healthcare, The Netherlands


Most tests applied in microbiological QC are described in detail in the different Pharmacopoeias (e.g. EP, USP, and JP). These methods are regarded as being validated – but not for your products!

In the end, it is up to you to prove that the official methods function in your environment.

The validation of microbiological test methods for your needs consumes a lot of time, money and manpower. Things can get more complicated if your products interfere with the execution of the test.

The real challenge is to fulfil both, regulatory requirements and at the same time financial targets set by your Management.

During this 3-day workshop you develop strategies for a sustainable approach perform  microbiological test procedures in compliance with the regulations. This course will give you clear guidance on how to cope with these tasks besides your routine laboratory work.

The key tool of this seminar will be team work. During interactive sessions you will create procedures for the most common microbial test methods. Our experienced ECA course leaders will moderate the discussions to lead you to practice-oriented solutions.
After completion of the course you will be able to run microbiological test procedures in a compliant and at the same time efficient manner.

This Live Online Training will provide practical guidance on implementing the harmonized test methods as well as alternative microbiological methods!

Target Group

This GMP Training is designed for microbiologists, managers and supervisors of pharmaceutical microbiological laboratories.
Furthermore, the course will be of interest to personnel from quality control, quality assurance, regulatory affairs and contract laboratories involved in the microbiological aspects of the production and testing of medicinal products.

Technical Requirements

We use WebEx Events for our live online training courses and webinars. At you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Programme Day 1

Module 1:
Basic Requirements for Microbiological Laboratories

Lab Layout and Equipment Qualification
  • Clean and dirty concepts
  • Avoiding cross contamination
  • Lay out requirements for a PCR Lab
  • Equipment qualification – points to consider for a microbiological lab
Method Suitability Test vs. Microbiological Method Validation 
  • Designing a MST strategy
  • Worked examples of MST, creams, liquids, tablets.
  • MST for  difficult formulations
  • Transferring methods to other laboratories, what do you need?
  • Microbial cultures, selection and maintenance
  • Microbiological media: how to make it, store it and test it
  • Background and revision of chapter Ph. Eur. 5.1.6
  • Validation process
  • Accuracy, precision, specificity, LOD, LOQ, linearity, range, robustness
  • Case study for the Milliflex Quantum System
Module 2:
Compliant Microbiological Test Methods

Microbial Enumeration Test for Non-Sterile Products
  • The harmonised approach USP/Ph.Eur. /JP
  • Relevant parameters in the test procedure
  • Choosing the most suitable test method
  • Microbial quality of excipients, APIs and final dosage forms
  • Defining alert levels based on historical data
  • The approach of risk assessment testing
Tests for Specified Microorganisms
  • Testing Methods
  • Challenges concerning the suitability testing
  • How to choose the right growth media supplier
  • What are objectionable micro-organisms
Bacterial Endotoxins/Test Validation
  • Principles of the techniques
    • Gel-clot techniques
    • Photometric techniques
  • Preparatory testing / validation tests
  • LER
Testing of Pharmaceutical Water
  •  Regulation and requirements for pharmaceutical water
  •  Validation of water Systems
  •  Water testing & deviation handling
The Test of Sterility
  • Media
  • Method suitability tests
  • Test procedures
    • Membrane filtration method
    • Direct transfer or direct inoculation method
Programme Day 2

Rapid Microbiological Methods
  •  Overview on the current RMMs
  •  Limitations and benefits of the different RMM?
Environmental Monitoring
  •  Monitoring of non-sterile processes
  •  Aseptic manufacture:
    • developing a Programme
    • interpreting data
    • regulatory requirements
  •  Monitoring methods; air, surface, people
  •  A complete programme for a sterile product
Module 3:
Further Challenges in Modern Microbiological Labs

Identification Techniques – Phenotypic / Genotypic
  • Phenotypic and genotypic identification techniques - advantages and limitations
  • A change from phenotypic to genotypic identification and the  surprises
  • New methods - what’s in sight?
Training and Qualification of Analysts
  • A structured training Programme for microbiologists - what they need to know and why
Disinfection – Efficacy Testing and Validation
  • Antimicrobial agents and their efficacy
  • Testing methods
  • Efficacy testing against isolates
  • Validation Approach
  • Guidelines
Change Control
  • Capturing changes in your process.
  • When is a change not a change?
  • Change control after the event!
  • Your change control process, making it robust
Programme Day 3
Dealing with OOS Results
  • How do we define alert and action limits?
  • How should we react on Out-Of-Specification results?
  • How can we perform a proper Failure Investigation?
Module 4:
The Real World - Case Studies and Examples

Risk Assessment
This part of day 3 will give you an insight in trending of microbiological data and principles of microbiological risk assessments. It will cover the regulatory background like ICH Q9 and make you familiar with risk identification  tools like FMEA (Failure Mode and Effects Analysis) or FTA (Fault Tree Analysis).

The Harmonized Methods for Testing of Non-Sterile Products
The goal of this session is to encourage the participants to think globally when analyzing microbiology problems. Microbiology problems are subtle and often multifactorial in their origin. The examples will show you tips and tricks in testing methods and a possibility to discuss the issues of the implementation of the harmonized methods like growth promotion testing, creating an implementation concept and necessary investments.

Environmental Monitoring – Set-Up and Deviations
This presentation gives you an understanding of how to set-up an environmental monitoring programme, and how to handle excursions. The discussions will focus on initial qualification vs. routine monitoring, how many samples are reasonable, reporting structure of environmental monitoring data, corrective actions and the impact of environmental data on product release.

Rapid Microbiological Methods – Regulatory Background and Implementation
This session offers you a unique possibility to evaluate the new developments in RMM systems to extend the experiences in validation and implementation of these systems in pharmaceutical industry. Furthermore you will learn more about the expectations of European and US authorities.

Go back

GMP Conferences by Topics