Dr Andreas Flückiger
Formerly F. Hoffmann-La Roche
Referierende
Nikolaus Ferstl
Facility Engineering Services
Robert G. Schwarz
GXP-TrainCon
Dr Markus Keller
Fraunhofer Institute for Manufacturing Engineering and Automation (IPA)
Dr Rainer Gnibl
GMP Inspector
Highlights
- Regulatory Requirements: Contamination Control Strategy & Cross Contamination
- Containment: Avoiding Exposure - Minimizing Cross Contamination
- Cross Contamination through Poor Organisation, Poor HVAC & Equipment Design
- GMP Inspector’s View on Cross Contamination
- Cleaning & Cleaning Validation
- Containment: Avoiding Exposure - Minimizing Cross Contamination
- Cross Contamination through Poor Organisation, Poor HVAC & Equipment Design
- GMP Inspector’s View on Cross Contamination
- Cleaning & Cleaning Validation
Zielgruppe
This training is aimed at Production, QA and engineering Departments of pharmaceutical companies to maintain product quality and patient safety in a regulatory compliant and agile production life cycle. Suppliers for the pharmaceutical industry are also addressed in order to better understand the requirements of their customers.
Zielsetzung
This GMP training aims at unveiling possible risks of cross contamination during the production process of pharmaceutical products and APIs. This is especially important for patients’ safety, product quality and to be in compliance with chapters 3 and 5 of the EU GMP regulation. The prevention of cross contamination has to be documented accordingly taking into consideration QRM principles according to ICH Q9.
Learn:
- How to detect possible risks
- How to avoid cross contamination
- How to prove the avoidance of cross contamination
- Ho to document a regulatory-compliant strategy
Programm
Regulatory Requirements: Contamination Control Strategy & Cross Contamination
- The view of EMA
- The view of US-FDA
- Shared facilities regulations
- Contamination and sterile products
Sources of Contamination – Modes of Cross Contamination – Segregation
- Do different sources mean different impact?
- Where cross contamination could occur and different likelihoods
- Is segregation a no brainer?
- Cross contamination in Biotech
Containment Solutions – Avoiding Exposure – Minimizing Cross Contamination
- Exposure and how to calculate it
- Equipment and containment concepts
- Closed product handling
- Sampling
- Material Transfer
- The PDE/ADE concept: how much contamination is allowed?
- Avoiding cross contamination
- Airborne contamination
- Contamination of surfaces
- Containment verification
Cross-Contamination from the Perspective of a GMP Inspector
- GMP inspector's expectations for avoiding cross-contamination (including organizational and technical measures)
- How to decide: dedicated or shared facility?
- Annex 1 and the requirements for non-product-contact surfaces
- Cleaning validation and cross contamination
Cross Contamination through poor Organisation
- Organisational points to consider
- The human factor
- The importance of training and motivation
Cross Contamination through poor HVAC Design
- Airborne particles
- Pressure / hygienic zones – maintaining over pressure
- The clean corridor concept
- Simulation and visualisation of air flow
- Classification of ventilation systems
- Concepts for HVAC systems
- Components of AHUs (filters, Duct work, etc...)
- Classification and change of filters
- Control and monitoring strategies
Cross Contamination through poor Equipment Design
- Cleanability of equipment as the key to avoiding crosscontamination
- In-line cleanability? – Cleanability for parts that are disassembled?
- Importance of drainability (cross contamination by product and detergent residues)
- Gap-free and dead-space-free design of system components
- Components (connections, valves, pumps, sensors)
- Mixing and preparation vessels, bioreactors
- Cross contamination due to lack of technical support
- Deterioration of surface Quality
- Wear of static and dynamic seals
Cleaning & Cleaning Validation
- Poor Cleaning – main reason for cross contamination
- Dealing with multipurpose strategies in cross contamination control
- Cross contamination – main focus of cleaning Validation
Documentation: CCS, HBEL assessment, QRM
- Cross contamination control and CCS
- HBEL – from the environmental risk to patient’s risk
- Cross contamination control – it is all about QRM
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At 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.
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.
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 Robert Eicher, +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Tue., 04 May 2027, 09:00-17:00 h
Wed., 05 May 2027, 09:00-16:45 h
All times mentioned are CEST.
Wed., 05 May 2027, 09:00-16:45 h
All times mentioned are CEST.
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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