- Datum:
-
- Konferenz
Visual Inspection of Parenterals PLUS Pre-Course Fundamentals of Visal Inspection
- Veranstaltungsort:
- Berlin
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
Pre-Conference Course: Fundamentals of Visual Inspection
5 November 2024
General requirements
- Requirements of the Pharmacopeia
- Defect categorisation
- Test kits for training, qualification and routine
Manual Inspection
- Qualification and training of personnel
- Standardisation of working conditions
- AQL in the manual inspection
From Manual to automated Inspection
- Usage of the Knapp and the modified Knapp test
- Cross validation during the PQ Phase
- Evaluation matrices
Automated Inspection
- Importance of particle detection rates
- System-Suitability, Requalification and revalidation
Evaluation of Inspection Data & Batch Release
- Trending of inspection results
- AQL Testing
- Re-inspection – allowed or not?
Conference: Visual Inspection of Parenterals
6/7 November 2024
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
- 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 adapted.
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 adapted.
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
Establishing a Company-Wide Program for Harmonisation of Visual Inspection and Particle Reduction
This presentation will guide you through a success story of developing and executing a global, company-wide visual inspection and particle life cycle management program at a large Pharmaceutical company. Takeda has put a high focus on visual inspection and visible particles since 2020 and has achieved harmonization across their network of 15 sites and 13 CMOs as well as tremendous improvements in particle reduction and life cycle management. This presentation will provide an overview of the strategy, challenges, and achievements as well as learnings from the program.
This presentation will guide you through a success story of developing and executing a global, company-wide visual inspection and particle life cycle management program at a large Pharmaceutical company. Takeda has put a high focus on visual inspection and visible particles since 2020 and has achieved harmonization across their network of 15 sites and 13 CMOs as well as tremendous improvements in particle reduction and life cycle management. This presentation will provide an overview of the strategy, challenges, and achievements as well as learnings from the program.
- Learnings from Takeda's global program
- New challenges for particle LCM in small-scale manufacturing of ATMPs
- Alignment with evolving regulations
- Adaption to other companies
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?)
Case Study Amgen: Use of AI in Visual inspection
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
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
