Felix Krumbein
Head ECA Visual Inspection Group
Referent:innen
Christof Langer
OSConsulting
Haluk Dönmez
B. Braun
Dr. Daniel Müller
GMP Inspector
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)
- How to comply with FDA’s new guidance on Visual Inspection
- Compliance with the new 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 set up a company-wide particle reduction Programme
- 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 November 5th.
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.
All participants receive the current version of ECA’s Best Practice Paper on “Visual Inspection” for free.
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
Current FDA Requirements for Visual Inspection of Injectables (remote presentation)
- Difference between current FDA and EU requirements
- Use of quality risk management for the prevention of visible particulate contamination
- FDA Visible Particulate case studies
- Drug-Device combination product considerations
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 4.0 of the ECA Guide
The new version 4.0 of the ECA guide has recently been released. The presentation will introduce the guide itself and the changes in the new version. Among other things a chapter on semi-automated visual inspection 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 new version 4.0 of the ECA guide has recently been released. The presentation will introduce the guide itself and the changes in the new version. Among other things a chapter on semi-automated visual inspection 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.
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 personal
- Typical inspection errors and walkarounds
Practical Approaches for the Inspection of hard-to inspect Container Systems
Part I
Part I
- Inspection of Bags
- 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
- Use of artificial intelligence
- General Approach
- Training and Machine Learning
- Testing and Validation
- Limitations
Particle Lifecycle Concept
- What does it tell about the product?
- What can we learn about the visual inspection process and operator qualification?
- Challenges and first experiences
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
Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..
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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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