Dr Sven Deutschmann
Roche Diagnostics
Referent:innen
Dr Holger Kavermann
Roche Diagnostics
Dr Marcel Goverde
MGP Consulting
Emine Floret
MGP Consulting
Zielsetzung
Most tests applied in microbiological QC are described in detail in the different Pharmacopoeias (e.g. Ph.Eur., USP, and JP). These methods are regarded as being validated. Nevertheless, the user has to demonstrate that the sample to be tested does not interfere with the method described in the pharmacopeias. 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.
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 to 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.
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.
To guarantee optimal conditions for the exchange of opinions and experiences, the number of participants is limited!
This course will provide practical guidance on implementing the harmonized test methods as well as alternative microbiological methods!
This course will provide practical guidance on implementing the harmonized test methods as well as alternative microbiological methods!
Zielgruppe
This GMP Workshop 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.
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.
Date / Venue / Presentations / Certificate
Date
Tuesday 23 September 2025, 09.00 – 18.00 h
(Registration and coffee 08.30 -09.00 h)
Wednesday, 24 September 2025, 09.00 – 18.00 h
Thursday, 25 September 2025, 08.30 – 13.30
Venue
Barcelo Sants Hotel
Pl. Països Catalans, s/n
08014 Barcelona, Spain
Phone +34 93 503 53 00
Email sants@barcelo.com
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Module 1:
Basic Requirements for Microbiological Laboratories
Training and Qualification of Analysts
Basic Requirements for Microbiological Laboratories
Training and Qualification of Analysts
- A structured training programme for microbiologists - what they need to know and why
- Training – What and Why?
- Training – How?
- Training – Effectiveness check
- Training – For cleanroom operators
Lab Layout and Equipment Qualification
- Clean and dirty concepts
- Avoiding cross contamination
- Layout requirements for a PCR Lab
- Equipment qualification – points to consider for a microbiological Lab
Method Suitability Test vs. Microbiological Method Validation
- When do we perform an MST and when validation?
- Validation according to Ph. Eur. chapter 5.1.6
- 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
Compliant Microbiological Test Methods
Microbial Enumeration Test for Non-Sterile Products
- Microbial enumeration test according to the harmonised Methods
- Relevant parameters in the test procedure
- Choosing the most suitable test method
- Microbial quality of excipients, API 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
- Challenges with the growth promotion test
- How to evaluate objectionable micro-organisms
Bacterial Endotoxins/Test Validation
- Introduction
- Test principles
- Methods and method validation
- Trouble Shooting
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
Alternative Microbiological Methods
- Introduction
- Overview of Alternative (Rapid) Microbiological Methods
- Potential applications
Environmental Monitoring
- Guidelines
- Clean room classification
- Monitoring methods and Instruments
- Monitoring program based on a risk assessment
- Interpreting and trending data
Module 3:
The Real World - a Workshop Day
Interactive Sessions
These interactive sessions are an excellent forum for fruitful discussions. You will develop testing and validation strategies that can be transferred directly to your lab. The ECA course leaders take care that you stay focused on the pre-defined exercises.
1. The Harmonized Methods for Testing of non-sterile Products
The goal of this workshop is to encourage the participants to think globally when analysing microbiology problems. Microbiology problems are subtle and often multifactorial in their origin. The workshop 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.
2. Alternative Microbiological Methods
This workshop offers the opportunity to exchange information with colleagues and the moderator of the workshop about their experience in the validation, implementation, and submission of alternative microbiological methods.
In an introductory lecture you will learn more about the expectations of the European and US authorities. The following Q&A round can be used to exchange knowledge regarding the validation and submission of e.g. alternative PCR-based Adventitious Agents detection methods, alternative sterility tests, or automated colony counting devices.
3. Microbial Control Risk Assessment
This workshop 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).
4. Environmental Monitoring
The workshop gives you an understanding on how to set-up an environmental monitoring program based on room classification and risk assessments. The focus will be set on routine monitoring including sample location and frequency, data trending and evaluation. Further laboratory assessment during excursions and manufacturing contaminations will be discussed.
Please select 3 workshops when registering!
The Real World - a Workshop Day
Interactive Sessions
These interactive sessions are an excellent forum for fruitful discussions. You will develop testing and validation strategies that can be transferred directly to your lab. The ECA course leaders take care that you stay focused on the pre-defined exercises.
1. The Harmonized Methods for Testing of non-sterile Products
The goal of this workshop is to encourage the participants to think globally when analysing microbiology problems. Microbiology problems are subtle and often multifactorial in their origin. The workshop 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.
2. Alternative Microbiological Methods
This workshop offers the opportunity to exchange information with colleagues and the moderator of the workshop about their experience in the validation, implementation, and submission of alternative microbiological methods.
In an introductory lecture you will learn more about the expectations of the European and US authorities. The following Q&A round can be used to exchange knowledge regarding the validation and submission of e.g. alternative PCR-based Adventitious Agents detection methods, alternative sterility tests, or automated colony counting devices.
3. Microbial Control Risk Assessment
This workshop 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).
4. Environmental Monitoring
The workshop gives you an understanding on how to set-up an environmental monitoring program based on room classification and risk assessments. The focus will be set on routine monitoring including sample location and frequency, data trending and evaluation. Further laboratory assessment during excursions and manufacturing contaminations will be discussed.
Please select 3 workshops when registering!
Module 4:
Further Challenges in Modern Microbiological Labs
Identification Techniques – Phenotypic / Genotypic
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?
Dealing with Alert, Action and OOS Results Guidelines
- Alert and action excursions EM and UM
- Alert, action and OOS excursions product
- Limit excursion assessments and laboratory investigations
Disinfection – Efficacy Testing and Validation
- Guidelines
- Antimicrobial agents and their efficacy
- Efficacy studies - disinfectants, surfaces and isolates
- Disinfectant strategy - testing and validation
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
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
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E-Mail: info@concept-heidelberg.de
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