FRANZ TRAINING & PROJECTS

PRESENTS;

ModernMicrobiology
Laboratory
Best LabPractice
27-29August2025 | BalalaikaProteaHotel|Sandton–South Africa.

Highlights:
▪ Basic Requirements for Microbiology Labs
- Lab Layout/MST/Operator Qualification
▪ Compliant Microbiological Test Methods
- Classic Methods: Limit Test / Endotoxin / Sterility / Specified MO
- Modern Methods: RMM/LIMS
▪ The Real World - A Workshop Day
- Harmonized Methods for Testing of non-sterile Products
- Alternative Microbiological Methods
- Microbial Control Risk Assessment
- Environmental Monitoring
▪ Further Challenges in the Micro Lab
- ID Techniques / OOS Handling / Change Control /
Validation According EP 5.1.6.

Mastering the challenges of classic

and modern microbiological methods

REGISTER NOW> T +27 11 568 4724 M +27 81 316 6719 E: [email protected] W: www.franztraining.co.za
 Modern Microbiology Laboratory
27-29 August, 2025
Objective Programme:
Most tests applied in microbiological QC are described in detail Module 1:
in the different Pharmacopoeias (e.g. Ph.Eur., USP, and JP). These Basic Requirements for Microbiological Laboratories
methods are regarded as being validated. Nevertheless, the user
has to demonstrate that the sample to be tested does not inter- Training and Qualification of Analysts
fere with the method described in the pharmacopeias. In the
end, it is up to you to prove that the official methods function in ▪ A structured training programme for microbiologists -
your environment. what they need to know and why
- Training – What and why?
The validation of microbiological test methods for your needs - Training – How?
consumes a lot of time, money and manpower. Things can get - Training – Effectiveness check
more complicated if your products interfere with the execution - Training – For cleanroom operators
of the test.
Lab Layout and Equipment Qualification
The real challenge is to fulfil both, regulatory requirements and
at the same time financial targets set by your management. ▪ Clean and dirty concepts
▪ Avoiding cross contamination
During this 3-day workshop you develop strategies for a sustain- ▪ Layout requirements for a PCR Lab
able approach to perform microbiological test procedures in ▪ Equipment qualification – points to consider for a
compliance with the regulations. This course will give you clear microbiological Lab
guidance on how to cope with these tasks besides your routine
laboratory work. Method Suitability Test vs. Microbiological Method
Validation
The key tool of this seminar will be team work. During
interactive sessions you will create procedures for the most ▪ When do we perform an MST and when validation?
common microbial test methods. Our experienced course leader ▪ Validation according to Ph. Eur. chapter 5.1.6
will moderate the discussions to lead you to practice-oriented ▪ Accuracy, Precision, Specificity, LOD, LOQ, Linearity,
solu- tions. Range, Robustness

After completion of the course you will be able to run microbio-

logical test procedures in a compliant and at the same time effi- Module 2:
cient manner. Compliant Microbiological Test Methods

To guarantee optimal conditions for the exchange of opinions Microbial Enumeration Test for Non-Sterile Products
and experiences, the number of participants is limited!
▪ Microbial enumeration test according to the harmonised
This course will provide practical guidance on implementing the methods
harmonized test methods as well as alternative microbio- logical ▪ Relevant parameters in the test procedure
methods! ▪ Choosing the most suitable test method
▪ Microbial quality of excipients, API and final dosage forms
▪ Defining alert levels based on historical data
Target Audience ▪ The approach of risk assessment testing

This Workshop is designed for microbiologists, managers and Tests for Specified Microorganisms
supervisors of pharmaceutical microbiological laboratories.
▪ Testing Methods
Furthermore, the course will be of interest to personnel from ▪ Challenges concerning the suitability testing
quality control, quality assurance, regulatory affairs and con- ▪ Challenges with the growth promotion test
tract laboratories involved in the microbiological aspects of the ▪ How to evaluate objectionable micro-organisms
production and testing of medicinal products.
Bacterial Endotoxins/Test Validation

▪ Introduction
▪ Test principles
▪ Methods and method validation
▪ Trouble shooting

REGISTER NOW> T +27 11 568 4724 M +27 81 316 6719 E: [email protected] W: www.franztraining.co.za
 Modern Microbiology Laboratory
27-29 August, 2025
Module 4:
Testing of Pharmaceutical Water
Further Challenges in Modern Microbiological Labs
▪ Regulation and requirements for pharmaceutical water Identification Techniques – Phenotypic / Genotypic
▪ Validation of water systems
▪ Water testing & deviation handling ▪ Phenotypic and genotypic identification techniques -
advantages and limitations
The Test of Sterility ▪ A change from phenotypic to genotypic identification and
the surprises
▪ Media ▪ New methods - what’s in sight?
▪ Method suitability tests
▪ Test procedures Dealing with Alert, Action and OOS Results
- Membrane filtration method Guidelines
- Direct transfer or direct inoculation method
▪ Alert and action excursions EM and UM
Alternative Microbiological Methods ▪ Alert, action and OOS excursions product
▪ Limit excursion assessments and laboratory
▪ Introduction investigations
▪ Overview of Alternative (Rapid) Microbiological Methods
▪ Potential applications Disinfection – Efficacy Testing and Validation

Environmental Monitoring ▪ Guidelines

▪ Antimicrobial agents and their efficacy
▪ Guidelines ▪ Efficacy studies - disinfectants, surfaces and isolates
▪ Clean room classification ▪ Disinfectant strategy - testing and validation
▪ Monitoring methods and instruments
▪ Monitoring program based on a risk assessment Change Control
▪ Interpreting and trending data
▪ Capturing changes in your process
Module 3: The Real Word Workshop Day ▪ When is a change not a change?
• The Harmonized Methods for Testing of non-sterile ▪ Change control aker the event!
Products ▪ Your change control process, making it robust
• Alternative Microbiological Methods
• Microbial Control Risk Assessment
• Environmental Monitoring

COURSE EXPERT:

Associate. Professor. Timothy Sibanda, PhD

Having presented at various international conferences in Europe, Middle East,
Asia and Africa. Prof.Timothy Sibanda is a well published microbiologist
with extensive expertise in microbial ecology, molecular diagnostics, and
biotechnological applications of extremophiles.
With a PhD in Microbiology from the University of Fort Hare, his work bridges
fundamental microbial physiology and applied research addressing food security,
environmental remediation, and industrial microbiology.

Prof. Sibanda is highly skilled in aseptic techniques, microbial

culturing, genome sequencing, bioinformatics, and the design of synthetic
microbial systems. He is also proficient in conducting antibiotic susceptibility
testing, metabolic pathway analysis, and high- throughput screening of
microbial consortia.

His ability to isolate, characterize, and manipulate microorganisms underpins his contributions to biocontrol strategies,
microbial inoculant development, and mycotoxin detoxification. Beyond laboratory competence, he is an articulate
science communicator and collaborative researcher, with a strong record of interdisciplinary projects and postgraduate
supervision.
His work continues to enhance our understanding of microbial roles in sustainable development and health. He is
currently Associate Professor of Microbiology at the University of the Witwatersrand in Johannesburg.
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REGISTER NOW> T +27 11 568 4724 M +27 81 316 6719 E: [email protected] W: www.franztraining.co.za