Dr Anthony Bevilacqua
Mettler-Toledo-Thornton
Referierende
Markus Multhauf
Consultant Pharmaceutical Engineering
Stephan Löw
CSL Behring
Highlights
- Current GMP and Pharmacopoeial Requirements
- Engineering, Commissioning & Qualification of Pharmaceutical Water Systems
- Microbiological Control of GMP Water Systems: Monitoring & Sanitisation
Zielgruppe
This GMP course is directed at engineers and production and QA/QC staff responsible for the design, validation and operation of pharmaceutical water systems, as well as system suppliers.
Zielsetzung
The objective of this course is to enable you to pay optimal attention to critical issues during design, qualification and routine operation of pharmaceutical water systems.
You will learn:
- How to meet the pharmacopoeial requirements
- How to find the critical design aspects in a water system
- How to generate pharmaceutical water and steam in the desired quality
- How commissioning and qualification are done today
- How microbial control is achieved
Programm
Overview of Global Pharmacopoeial Requirements and Recent Changes for Pharmaceutical Waters
- Current GMP trends and Pharmacopoeial requirements for pharmaceutical waters
- Requirements for Bulk Pharmaceutical Waters – Purified Water, WFI and Pure Steam
- Requirements for sterile and packaged pharmaceutical waters - Harmonisation and future requirements of the U.S., European, and Japanese Pharmacopoeias
State-of-the-art Pharmaceutical Water Generation
During the planning of a pharmaceutical water generation plant the influence of the feed water is often underestimated. A reliable and economically feasible system is only obtainable under consideration of the unique feed water chemistry. The Engineering phase of the project serves to make the important decisions regarding choice of technology, such as double pass RO vs. RO combined with electrodeionization.
During the planning of a pharmaceutical water generation plant the influence of the feed water is often underestimated. A reliable and economically feasible system is only obtainable under consideration of the unique feed water chemistry. The Engineering phase of the project serves to make the important decisions regarding choice of technology, such as double pass RO vs. RO combined with electrodeionization.
- Overview of different water treatment technologies and their suitability for pharmaceutical applications
- PW and HPW generation with membrane processes (RO/EDI)
- WFI generation with and without distillation
- Pure Steam Generation
Water Storage and Distribution
- Engineering Details
- Water storage
- Water distribution
- Conception of Loops
- Quality attributes to measure in the loop
- Sampling issues
Modern Sanitisation Concepts
- Sanitisation with heat
- Sanitisation with chemicals (incl. Ozone)
- Combination of different methods
- Sanitisation cycles
- Sanitisation after breakdown and deviations
What you need to know: Stainless Steel: Piping and Equipment
- Composition and properties of stainless steels for water and steam systems
- Surfaces of stainless steels and their treatment
- GMP-compliant welding of Piping systems
- Rouging of stainless steels: current understanding and strategies to deal with connections, heat exchangers, valves & pumps
- Documentation and material certificates
Technical Specialities during the Qualification of Water Systems
- Risk-based approach to validation of a pharmaceutical water system
- Critical components and parameters
- Modern qualification and commissioning
- Package Unit approach
- Critical timelines
Microbiological Control of Water Systems
- Common microbial inhabitants of pharmaceutical water systems
- Definition of ‘objectionable organisms’ as pseudomonas
- Sources of contamination and Biofilms
- Microbiological aspects of pharmaceutical water system validation
- The three qualification phases
- Routine microbiological monitoring (sampling frequency and Locations)
- Review, interpretation and reporting of microbiological data
- Handling OOS results in pharmaceutical water systems
Weitere Informationen
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
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 upon receipt of invoice.
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 upon receipt of invoice.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
You cannot attend the Live Event?
Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Contacts
Questions regarding content:
Dr Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Maximillian Bauer, +49 6221 84 44-25, bauer@concept-heidelberg.de
Questions regarding content:
Dr Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Maximillian Bauer, +49 6221 84 44-25, bauer@concept-heidelberg.de
Datum & Uhrzeiten
Thu, 11 Feb 2027, 09:00-17:15 h
Fri, 12 Feb 2027, 09:00-13:15 h
Fri, 12 Feb 2027, 09:00-13:15 h
Times mentioned are CET.
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
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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