Dr Hans-Joachim Anders
Novartis Pharma Stein
Referierende
Markus Multhauf
Consultant Pharmaceutical Engineering
Dr Michael Miller
Microbiology Consultants
Dr Harmen Hawer
Panpharma
Dr Jürgen Illerhaus
BWT Aqua
Feng Jin Liew
Mettler-Toledo-Thornton
Isabel Mabrito
Mettler-Toledo-Thornton
Highlights:
- Rapid Water Monitoring Systems – Case Studies
- Validation of Alternative Methods for Microbiological Examination of Water
- Case Studies of Contamination in Pharmaceutical Water Systems without Microbial Online Monitoring
Zielgruppe
This course is intended for professionals and staff in the fields of microbiology, quality assurance, engineering, and production who are involved in the design and microbiological control of pharmaceutical water systems.
Zielsetzung
The aim of this event is to provide information on current applications of online microbial monitoring of pharmaceutical water and to demonstrate the state of the art. Case studies are used to demonstrate the online detection of contamination in water systems. It will also be shown how alternative methods for microbiological examination of water can be validated.
Programm
Rapid Microbial Methods for PW and WFI – Application Notes from a Technical Point of View
- Regulatory Recommendations and Practical Hurdles
- How to Generate a Return on Investment – Application Examples & Limitations
- Remarks on Rapid Microbial Methods and At-Line Particle Measurements
- Data and Studies on Drinking Water and Ultrapure Water in the Semiconductor Industry
Demonstrating Comparability and Changing Acceptance Levels for Biofluorescent Particle Counter (BFPC) Rapid Water Monitoring Systems
- Understand the Difference between the CFU and New Signals from BFPC Technologies
- Learn How Regulators and the Compendia Are Addressing Next-Generation Rapid and Alternative Methods
- Review the New PDA Technical Report #33 Recommendations for Demonstrating Comparability between CFU and Non-CFU Methods and How to Establish Acceptance Levels Based on the New Signal
Case Study: Usage of BWT’s AquaSense
- Introduction to AquaSense (BWT)
- Methodology and Detection Principle
- Results of the Evaluation and Validation
- Attempt to Explain Elevated Bacterial Count Findings
- Discussion Regarding Potential Use in Plant Monitoring
Validation of Alternative Methods for Microbiological Examination of Water
- Count of all living Microorganisms including VBNC
- Online Bioburden Monitoring in Near Real Time
- Validation for Intended Use
- Regulatory Requirements
Undetected until Too Late: Case Studies of Contamination in Pharmaceutical Water Systems without Microbial Online Monitoring
- Major Microbiological Risks in Pharmaceutical Water Systems
- Biofilm Formation and the Underestimated Relevance of Gram-Negative Bioburden Findings
- Case Studies of Microbial Contamination Events
- The Role and Importance of Online Monitoring as an Early Warning System
- Operational Impact and ROI of Microbial Online Monitoring
Microorganisms Can Swim, but They Can’t Hide: The Detection of Microbial Excursions Using a Biofluorescent Particle Counter
- Introduction to the BFPC technology
- Challenges of the Conventional Method for Microbial Monitoring and Contamination Control
- Case Study of RMS Adoption in a Pharmaceutical Facility
- Performance Qualification of the Instrument: Establish AFU Baseline during Normal Operation
- Example of Microbial Excursion Detection Using Baseline Data
- Future outlook
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT)
ECA Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Dr Gehard Becker, +49 6221 84 44-65, becker@concept-heidelberg.de
Questions regarding organisation:
Ms Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT)
ECA Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Dr Gehard Becker, +49 6221 84 44-65, becker@concept-heidelberg.de
Questions regarding organisation:
Ms Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 29 Sep 2026, 14:00-18:00 h
Wed, 30 Sep 2026, 14:00-17:30 h
Wed, 30 Sep 2026, 14:00-17:30 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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