Dr Daniel Müller
GMP Inspector
Referent:innen
Felix Krumbein
Head ECA Visual Inspection Group
Martin Dearden
ECA Visual Inspection Group
Dr. Martin Becker
ECA Visual Inspection Group
Christof Langer
OSConsulting
Haluk Dönmez
B. Braun
Save € 400 when booking pre-conference course and conference together. Here you can register for both the Pre-Conference Course and the Conference.
Zielsetzung
Main topic of this conference is the detection of defects like particles in injectables and their evaluation. Besides the current regulatory requirements with regards to particulate matter, Routine 100% inspection of injectables will be addressed. Manual inspection as well as automated inspection systems will be covered, including validation, training, defect categories, AQL testing and trending.
Hintergrund
In most cases particles found in parenteral medicines will lead to a quarantined product or even to the recall of the product – as we have seen in the last years in the cases of several Pharmaceutical companies. Responsible staff in charge will have to start root cause analysis to find the source of the particles and will have to do an evaluation of batches already shipped.
There is still confusion within the global pharmaceutical Industry with regard to the requirements for testing for visible particles. After the USP chapters <790> and <1790> were published, things have become much clearer, at least for the US. In Europe chapter 5.17.2 of the European Pharmacopoeia now also gives further advice. However, many questions remain, e.g. concerning training, re-testing, detection capabilities and revalidation of inspection systems.
Furthermore, there has been a recognisable trend towards automated inspection machines throughout the last years. High expectations are also placed on the use of artificial intelligence. The challenge for pharmaceutical companies is to find a suitable machine for their products and to determine reasonable inspection parameters during qualification and validation. But also during routine process there are questions arising like re-testing and the usage of test-sets, doing AQL-Testing as well as the Adjustment of parameters of the vision system.
We will address those topics during the conference and discuss and answer questions on
- The latest compendial requirements concerning particulate matter (EU & US)
- Compliance with the revised EU Annex 1
- Implementation of artificial intelligence in the automated inspection process
- Reduction of false rejects in automated inspection Systems
- How to inspect hard-to-inspect containers
- How to transfer a visual inspection process during a site Change
The fundamentals, such as training of operators in manual inspection, AQL testing, trending and the validation of an AVI System are content of the Pre-Conference course on 21 October.
Zielgruppe
This course is directed at staff from sterile operations involved in the 100% inspection process, that is production, quality and engineering. But also suppliers of primary packaging materials and inspections technology are target group of this Event.
Additional Information, Date & Venue
Additional Information
All participants receive the new version 5.0 of ECA’s Guide on “Visual Inspection of medicinal products for parenteral use” for free.
Date
Wednesday, 22 October 2025, 09.00 to approx. 18.00 h
(Registration and coffee 08.30 – 09.00 h)
Thursday, 23 October 2025, 09.00 to approx. 15.00 h
Wednesday, 22 October 2025, 09.00 to approx. 18.00 h
(Registration and coffee 08.30 – 09.00 h)
Thursday, 23 October 2025, 09.00 to approx. 15.00 h
Venue
Doubletree by Hilton Vienna Schönbrunn
Schlossallee 8
1140 Wien
Phone: +43 1 89110
E-Mail: info@doubletree-schonbrunn.at
Doubletree by Hilton Vienna Schönbrunn
Schlossallee 8
1140 Wien
Phone: +43 1 89110
E-Mail: info@doubletree-schonbrunn.at
Programm
Gesamtes Programm als PDF herunterladen
Regulatory Requirements for the Visual Inspection of Parenterals
- Compendial requirements
- 100% visual inspection & AQL testing
- PharmEur, USP, JP - similarities and differences
- News from the Annex I
- Risk management considerations
Particulate Matter: Origins and Root Cause Analysis
- External sources (packaging material, filter, abrasion..)
- Internal sources (product and inherent particles)
- Potential risks for patients
- Route cause detection and particle identification
- Avoidance and depletion of particles
Visual Inspection of Parenterals – a GMP Inspector's View
- Applicable regulations & guidance
- Current requirements for pharmaceutical Industry
- Expectations of a GMP Inspector
- Examples of observations
Presentation of the new Version 5.0 of the ECA Guide
The presentation will introduce the guide itself and the changes in the new version 5.0. Among other things a chapter on difficultto-inspect items has been added. Also, the description of uninterrupted inspection times & breaks in manual visual inspection has been adapted. And the Annex 1 requirement for ‘Performance checks at regular intervals throughout the batch’ for AV inspection was taken into Account.
The presentation will introduce the guide itself and the changes in the new version 5.0. Among other things a chapter on difficultto-inspect items has been added. Also, the description of uninterrupted inspection times & breaks in manual visual inspection has been adapted. And the Annex 1 requirement for ‘Performance checks at regular intervals throughout the batch’ for AV inspection was taken into Account.
Refining Reject Analysis of Parenteral Containers
In this presentation a method is shown how to estimate precisely the actual defects in production batches. It allows improved trending based of defect severity
In this presentation a method is shown how to estimate precisely the actual defects in production batches. It allows improved trending based of defect severity
- Secondary inspection of rejected containers,
- Grouping defects by detection probability,
- Creating detailed control charts and data trends to better support batch disposition decisions
- Simulating outcomes using Monte Carlo statistical models
Semiautomated Inspection – Advantages and Risks
- Regulations for the use of SAVI
- Technical setup of a SAVI System
- Differences manual and semi-automated inspection
- Qualification of inspection personnel
- Typical inspection errors and walkarounds
Practical Approaches for the Inspection of hard-to inspect Container Systems [Remote Presentation]
Part I
Part I
- Inspection of Difficult to Inspect Parenteral Products
- Single chamber and multi-chamber bags
- Inspection of Blow-Fill-Seal containers
- Inspection of Form-Fill-Seal containers
- Manual, semi-automated and fully-automated approaches
- Two step inspection
Part II (Excursion)
- Use of artificial intelligence
- General approach machine learning
- Training, validation and testing
- False reject rates
- Limitations
Transfer of a Visual Inspection Process
- Manual inspection
- Manual process to manual process (same manufacturing location)
- Manual process to manual process (different manufacturing location)
- Test set transfer?
- Create new test set? How, why?
- What does validation look like?
- End goals and success (what are we trying to achieve?)
- Automated inspection
- Automated transfer: same machine (pitfalls)
- Automated transfer: different machine (pitfalls)
- End goals and success (what are we trying to achieve?)
Application, Project Planning and Qualification of AI in fully automated Visual Inspection
- Development of robust, reliable and production-ready models in 4 phases
- Phase 1: Problem identification & description
- Phase 2a: Specification of inspection Concept
- Phase 2b: Definition of the sample sets (artificial and production samples), creation of the datasets, clarification of the labelling strategy
- Phase 3: Model design, training and verification - a risk-based Approach
- Phase 4: Qualification & Validation
- Processes & Technologies
- Technologies for efficient image data acquisition, variable model technologies, transfer learning / pretrained models, labelling application
- Documentation of model development: traceability, risk minimisation and build-up of confidence
| 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
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
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E-Mail: info@concept-heidelberg.de
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