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.
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.
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!
Target Group
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.
Presentations / Certificate
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.
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. Risk Assessment and Trending 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
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Testimonials
Seminar Programme as PDF