Dr. Sven Deutschmann
Roche Diagnostics
Referent:innen
Dr. Marcel Goverde
MGP Consulting
Dr. Holger Kavermann
Roche Diagnostics
Emine Floret
MGP Consulting
All times mentioned are CET.
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 Live Online Training 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!
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!
Zielgruppe
This Live Online 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.
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 Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Module 1: Basic Requirements for Microbiological Laboratories
Lab Layout and Equipment Qualification
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
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: Further Challenges in Modern Microbiological Labs
Identification Techniques – Phenotypic / Genotypic
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
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
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
Module 4: The Real World - Case Studies and Examples
Trending and Risk Assessment
Trending and Risk Assessment
This session 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).
Harmonized Methods for Testing of Non-Sterile Products
The goal in this par tis to encourage the participants to think globally when analyzing microbiology problems. Microbiology problems are subtle and often multifactorial in their origin. We 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 track 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
Rapid Microbiological Methods – Regulatory Background and Implementation
This part offers additional information and 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.
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
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
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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