- Date:
-
- Webinar
15th Visual Inspection of Parenterals Conference PLUS Pre-Course Fundamentals of Visual Inspection - Live Online Training
- Event location:
- online
- Organizer:
- CONCEPT HEIDELBERG GmbH
Pre-Conference Course: Fundamentals of Visual Inspection
6 October 2026
General requirements
- Requirements of the Pharmacopeia
- Defect categorization
- Test kits for training, qualification, and routine
Manual Inspection
- Qualification and training of personnel
- Standardization of working conditions
- AQL in manual inspection
From Manual to Automated Inspection
- Use 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?
15th Visual Inspection of Parenterals Conference
7/8 October 2026
Regulatory Requirements for the Visual Inspection of Parenterals
- Compendial requirements
- 100% visual inspection & AQL testing
- PharmEur, USP, JP - similarities and differences
- News from Annex I
- Risk management considerations
Recent FDA Observations and Risk Assessment Approaches for Visual Inspection Control
- Recent FDA Form 483 and Warning Letter observations involving visual inspection and visible particulate manufacturing controls
- The regulatory and compendial basis for FDA concerns about visual inspection
- Risk assessment techniques for evaluating visual defect criticality, particle source, and patient impact
Particulate Matter: Origins and Root Cause Analysis
- External sources (packaging material, filter, abrasion..)
- Internal sources (product and inherent particles)
- Potential risks for patients
- Root 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 the pharmaceutical industry
- Expectations of a GMP inspector
- Examples of observations
Integrating USP <1790>, USP <790>, PDA TR 79 & ECA Visual Inspection Guidance into Modern Parenteral VI Practices
- Framework alignment: <790> (compliance), <1790> (science), TR 79 (lifecycle/DIPs), ECA v5.0 (practice)
- Human inspection capability: PoD and station standards
- Defect taxonomy & risk classification (DIP-aware)
- Method capability & qualification – per defect category
- Automated inspection (AVI): PoD-based validation & requalification
- Process control, trending & CAPA (lifecycle)
- Inspector training & requalification – per defect class
- Test set design – separate, blinded kits per category with adequate blanks
- Defect relevance, CCI, and special containers
- Continuous improvement & robustness
Visual Inspection from a Contract Manufacturer's Perspective
- The growing role of Automated Visual Inspection (AVI) in quality, efficiency, and compliance
- Key challenges of AVI implementation from a CDMO perspective
- Balancing standardization with customer-specific flexibility
- Managing regulatory expectations, internal quality requirements, and client demands
- Practical aspects of AVI governance and validation
- Collaboration with customers and technology suppliers throughout the system lifecycle
- Lessons learned from implementation, operation, and continuous improvement of AVI systems
Practical Approaches for the Inspection of Hard-to-Inspect Container Systems
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
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 labeling 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 / pre-trained models, labeling application
- Documentation of model development: traceability, risk minimization, and build-up of confidence
Multi-Color Image Processing for Detection of Particles in Difficult-to-Inspect Pharmaceutical Products
- Multispectral lighting and image processing enable the analysis of multiple information channels from a single image, improving the visibility of relevant details
- A single-camera approach can replace more complex multi-camera setups and provide the required inspection information in a compact format
- Combined lighting modes such as transmitted, reflected, and dark-field illumination help to highlight different material characteristics and defect types
- Intelligent image evaluation supports the reliable detection of defects such as particles, scratches, and contamination while reducing interference from regular packaging features.
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Germany
Phone: +49 6221 844415
Fax: +49 6221 844464
email: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
