Modern Microbiology Laboratory - Online Training Recording

Costs

*ECA-Member:**	EUR 1790,--
*Regular Fee:**	EUR 1990,--
*EU/GMP Inspectorates:**	EUR 995,--
*APIC Member Discount:**	EUR 1890,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

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

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 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 Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programme

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.

Recording from 6-8 December 2022

Duration of Recording: 15 h 22 min

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