Live Online Training: Microbiology for Non-Microbiologists

Live Online Training: Microbiology for Non-Microbiologists

Course No 18649

All times mentioned are CET.

Costs

ECA-Member: EUR 1590,--
Non ECA Member: EUR 1790,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

(All prices excl. VAT)

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

Speakers

Dr Hans-Joachim Anders, Novartis Stein, Switzerland
Dr Stefanie Bayer, Labor LS, Germany
Arjan Langen, GE Healthcare, The Netherlands
Axel H. Schroeder, Concept Heidelberg, Germany

Objectives

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.

Background

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.
  • 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:
  • 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.

Target Group

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 Requirements

For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

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
  • 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?
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?
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
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
Sterilisation Methods
  • Principles and kinetics of sterilisation
  • Selection of sterilisation method
  • Types of sterilisation methods
  • Validation of the sterilisation process
Examples and Case Studies Sessions
The objective of these special sessions is to give the participants some hands on experience with the fundamentals of microbial techniques and the difficulties associated with interpretation. Real cases will show sources of contamination, ways of root cause analysis and defining corrective and preventive actions.

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