Objectives

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 to performing microbiological testing 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 testing 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.

Programme

Module 1: Basic Requirements for Microbiological Laboratories

• Training and Qualification of Analysts
• Method Suitability Test - Requirements and Materials
• Method Validation According 5.1.6.

Module 2: Compliant Microbiological Test Methods

• Microbial Enumeration Test for Non-Sterile Products
• Bacterial Endotoxins/Test Validation
• The Test of Sterility
• Tests for Specified Microorganisms
• Rapid Microbiological Methods
• Environmental Monitoring

Module 3: The real world, A workshop day

Interactive Sessions

You will participate in 3 Workshops!

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.

• The harmonized methods for testing of non-sterile Products
• Rapid microbiological methods
• Risk assessment and trending
• Environmental monitoring

Module 4: Further Challenges in Modern Microbiological Labs

• Identification Techniques – Phenotypic / Genotypic
• Dealing with OOS Results
• Disinfection – Efficacy Testing and Validation
• Lab Layout and Equipment Qualification
• Change Control