Dr. Sven Deutschmann
Roche Diagnostics
Referent:innen
Dr. Holger Kavermann
Roche Diagnostics
Arjan Langen
GE Healthcare
Dr. Marcel Goverde
MGP Consulting
Zielsetzung
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.
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!
This Live Online Training will provide practical guidance on implementing the harmonized test methods as well as alternative microbiological methods!
Zielgruppe
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.
Programm
Programme Day 1
Module 1:
Basic Requirements for Microbiological Laboratories
Lab Layout and Equipment Qualification
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
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
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
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
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 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
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
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
| ECA-Member*: | € 1790,- |
| Regular Fee*: | € 1990,- |
| EU/GMP Inspectorates*: | € 995,- |
| APIC Member Discount*: | € 1890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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