Dr. Hans-Joachim Anders
Novartis Pharma Stein
Referent:innen
Dr. Stefanie Bayer
Labor LS
Arjan Langen
GE Healthcare
Axel Schroeder
Concept Heidelberg
Zielsetzung
It is the aim of this Live Online Training to familiarise responsible personnel from production, quality assurance and engineering with microbiological questions. The participants learn how to interpret microbiological data and which consequences these have for the production.
Hintergrund
The quality of drugs and the quality assurance during production are above all determined by their microbiological characteristics. The microbiological requirements on drugs are laid down in various regulations. When an authority inspects a company, it will focus its attention on these and on the requirements made on hygiene.
In their daily work, the responsible personnel in the production units has to understand microbiological results and evaluate their significance for further decisions. However, in practice many microbiological results are misinterpreted and thus often the wrong conclusions are drawn from them. When asked for the most frequent misinterpretations of microbiological results, pharmaceutical microbiologists gave the following answers.
In their daily work, the responsible personnel in the production units has to understand microbiological results and evaluate their significance for further decisions. However, in practice many microbiological results are misinterpreted and thus often the wrong conclusions are drawn from them. When asked for the most frequent misinterpretations of microbiological results, pharmaceutical microbiologists gave the following answers.
- The difference between bioburden and sterility testing (are they the same?)
- The use of disinfectants guarantees the sterility of the object, surface, culture treated.
- The distribution of microorganisms in a sample or on a surface is uniform.
- Motile microorganisms can swim hundreds of meters in an hour causing contamination problems in remote parts of the facility.
- How can different media formulations give different results?
- Microbial tests described in the Pharmacopoeias can always be validated, no matter what the matrix is, how aggressive it is, e.g. NaOH, how high the concentrations of antibiotics are etc.
- Identification results are absolute and unequivocal, especially when computer-generated.
- Underestimating the importance of cleaning prior to disinfection.
- Environmental monitoring results provide an accurate risk assessment during production.
- How can clean room surfaces not be heavily contaminated when the air counts are out of specification?
- How can endotoxins be present when the bioburden is nil?
- How can the titre of a virus reference standard change according to the detection cell line used?
- WFI is sterile.
- Filters are absolute.
- UV light disinfects and is capable of sterilising surfaces and water.
This listing appears to cover all aspects of microbiology from the interpretation of straight forward issues concerning environmental monitoring, bioburden results and identifications – through to the more complex issues surrounding virology results for the biologics/biotech people.
The misinterpretation of microbiological results often gives rise to the following misunderstandings:
The misinterpretation of microbiological results often gives rise to the following misunderstandings:
- Huge environmental monitoring programmes (more is better).
- Rejection of batches due to minor out-of- specification results.
- Delayed registration objectives and to attend appeal hearings.
- Numerous contamination incidents due to the application of inappropriate solutions to problems.
- Senseless promises made to regulatory authorities without scientific rationale based on the concept of quality.
Zielgruppe
This Live Online Training is designed for responsible personnel from production, quality assurance, regulatory affairs and engineering that has to make judgements, release products and take actions on the basis of the microbiological data supplied.
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 presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programm
The Characteristics of Microorganisms
- Fungi
- Bacteria
- Mycoplasma
- Viruses
- Cellular organisation, function
- Products, toxins, endotoxins, antibiotics, enzymes
Microbial Growth
- How it occurs
- What is required for growth?
- Growth kinetics – laboratory culture versus nature
- Effect of stress factors on growth
Microbial Identification Techniques
- What is the significance of a name?
- Distribution of microorganisms in nature, raw materials and water
- Distribution of microorganisms in pharmaceutical facilities
Detection Methods and their Limitations
- What can be detected by:
- The sterility test
- The bioburden test in its various forms:
- Membrane filtration, pour plate, spread plate, MPN
- The test for specified organisms
- The endotoxin test
- Limits of detection and factors effecting limits of detection
Cleaning, Sanitation, Disinfection
- Why cleaning before disinfection?
- The difference between cleaning and disinfection
- Disinfectants and their efficacy
- Methods of disinfection
- Disinfection validation
Environmental Monitoring
- Sampling techniques
- Air sampling
- Surfaces
- Settle plates
- Technical limitations and interpretation of results
- Is there a relationship between high results and contaminated product?
Case Studies on Monitoring and Hygienic Deviations
Pharmaceutical Water - Microbiological Control and Deviation Management
- Regulatory requirements
- Warning and action Limits
- Measures to be taken when warning and action Limits are exceeded
- Repeated non-conforming results
- Examples of warning and action limit exceedance
- Source of microbial contamination, biofilms
Sterilisation Methods
- Principles and kinetics of sterilisation
- Selection of sterilisation method
- Types of sterilisation methods
- Validation of the sterilisation process
Validation of Microbial Test Methods
- Basic principles of validating a microbial test system
- What approaches can you take when a microbial assay test cannot be validated?
How to Handle Microbiological OOS Results
- Typical Out-Of-Specification results
- Sterility testing
- Bioburden
- Endotoxin testing
- Cleanroom monitoring
- Investigation of causal connection
- Laboratory failure investigations
- Sampling/process/production failure Investigation
- Type of microorganisms
- Deviations/incidents/assessment
- Deviation/investigation report
- Retesting/Reanalysis/Resampling
- Definitions
- Calculation of mean values
- Rejection/Release
Trouble Shooting - Examples and Case Studies Sessions
The aim of these special sessions is to provide participants with practical experience of the basics of microbiological deviations and trouble shootings and the difficulties associated with evaluation. On the basis of real cases, sources of contamination, possibilities of root cause analysis and the determination of corrective and preventive measures are shown.
The aim of these special sessions is to provide participants with practical experience of the basics of microbiological deviations and trouble shootings and the difficulties associated with evaluation. On the basis of real cases, sources of contamination, possibilities of root cause analysis and the determination of corrective and preventive measures are shown.
Recording from 6/7 February 2024
Duration of Recording: 10 h
| ECA-Member*: | € 1690,- |
| Regular Fee*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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