Live Online Training - Modern Microbiology Laboratory
Course No 18423
All times mentioned are CET.
Costs
There is unfortunately no recording available for this Online Training Course. However, are you interested in participating in an upcoming Live Online date of this Training Course? Or do you need any assistance on our Training Courses & Conference programme? Then simply use the following contact form to send us your request.
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Sven M. Deutschmann, Roche Diagnostics GmbH, Germany
Dr Marcel Goverde, MGP, Switzerland
Dr Holger Kavermann, Roche Diagnostics GmbH, Germany
Arjan Langen, GE Healthcare, The Netherlands
Dr Marcel Goverde, MGP, Switzerland
Dr Holger Kavermann, Roche Diagnostics GmbH, Germany
Arjan Langen, GE Healthcare, The Netherlands
Objectives
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 course will provide practical guidance on implementing the harmonized test methods as well as alternative microbiological methods!
This course will provide practical guidance on implementing the harmonized test methods as well as alternative microbiological methods!
Target Group
This GMP Workshop 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 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
Programme Day 1
09.00 – 09.15 h Welcome and Organisationals
Module 1:
Basic Requirements for Microbiological Laboratories
09.15 – 10.15 h
Lab Layout and Equipment Qualification
09.00 – 09.15 h Welcome and Organisationals
Module 1:
Basic Requirements for Microbiological Laboratories
09.15 – 10.15 h
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
10.15 – 11.00 h
Method Suitability Test vs. Microbiological Method Validation
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
11.00 – 11.15 h Break
Module 2:
Compliant Microbiological Test Methods
11.15 – 12.00 h
Microbial Enumeration Test for Non-Sterile Products
Module 2:
Compliant Microbiological Test Methods
11.15 – 12.00 h
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
12.00 – 12.30 h
Questions and Answers
12.30 – 13.30 h Break
13.30 – 14.15 h
Tests for Specified Microorganisms
Questions and Answers
12.30 – 13.30 h Break
13.30 – 14.15 h
Tests for Specified Microorganisms
- Testing Methods
- Challenges concerning the suitability testing
- How to choose the right growth media supplier
- What are objectionable micro-organisms
14.15 – 15.15 h
Bacterial Endotoxins/Test Validation
Bacterial Endotoxins/Test Validation
- Principles of the techniques
- Gel-clot techniques
- Photometric techniques
- Preparatory testing / validation tests
- LER
15.15 – 15.30 h Break
15.30 – 16.15 h
Testing of Pharmaceutical Water
15.30 – 16.15 h
Testing of Pharmaceutical Water
- Regulation and requirements for pharmaceutical water
- Validation of water systems
- Water testing & deviation handling
16.15 – 17.15 h
The Test of Sterility
The Test of Sterility
- Media
- Method suitability tests
- Test procedures
- Membrane filtration method
- Direct transfer or direct inoculation method
17.15 – 18.00 h
Questions and Answers
Questions and Answers
Programme Day 2
09.00 – 09.45 h
Rapid Microbiological Methods
09.00 – 09.45 h
Rapid Microbiological Methods
- Overview on the current RMMs
- Limitations and benefits of the different RMM?
09.45 – 10.30 h
Environmental Monitoring
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
10.30 – 10.45 h Break
Module 3:
Further Challenges in Modern Microbiological Labs
10.45 – 11.45 h
Identification Techniques – Phenotypic / Genotypic
Further Challenges in Modern Microbiological Labs
10.45 – 11.45 h
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?
11.45 – 12.15 h
Question and Answers
12.15 – 13.15 h Break
13.15 – 14.15 h
Training and Qualification of Analysts
Question and Answers
12.15 – 13.15 h Break
13.15 – 14.15 h
Training and Qualification of Analysts
- A structured training Programme for microbiologists - what they need to know and why
14.15 – 15.15 h
Disinfection – Efficacy Testing and Validation
Disinfection – Efficacy Testing and Validation
- Antimicrobial agents and their efficacy
- Testing methods
- Efficacy testing against isolates
- Validation approach
- Guidelines
15.15 – 15.30 h Break
15.30 – 16.30 h
Change Control
15.30 – 16.30 h
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.
16.30 - 17.00 h
Questions and Answers
Questions and Answers
Programme Day 3
09.00 – 09.45 h
Dealing with OOS Results
09.00 – 09.45 h
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
09.45 – 10.30 h
Risk Assessment and Trending
The Real World - Case Studies and Examples
09.45 – 10.30 h
Risk Assessment and Trending
- 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).
10.30 – 10.45 h Break
10.45 – 11.30 h
The Harmonized Methods for Testing of Non-Sterile Products
10.45 – 11.30 h
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.
11.30 – 12.15 h
Environmental Monitoring – Set-Up and Deviations
11.30 – 12.15 h
Environmental Monitoring – Set-Up and Deviations
The last presentation of the day 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.
12.15 – 13.00 h
Rapid Microbiological Methods – Regulatory Background and Implementation
12.15 – 13.00 h
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.
13.00 – 13.30 h
Questions and Answers
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity