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
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
- 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
- Method suitability tests
- Test procedures
- Membrane filtration method
- Direct transfer or direct inoculation method
Alternative Microbiological Methods
- Overview of Alternative (Rapid) Microbiological Methods
- Potential applications
- Clean room classification
- Monitoring methods and Instruments
- Monitoring program based on a risk assessment
- Interpreting and trending data
The Real World - A Workshop Day
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!
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
- Antimicrobial agents and their efficacy
- Efficacy studies - disinfectants, surfaces and isolates
- Disinfectant strategy - testing and validation
- Capturing changes in your process
- When is a change not a change?
- Change control after the event!
- Your change control process, making it robust