15th Visual Inspection of Parenterals Conference PLUS Pre-Course Fundamentals of Visal Inspection - Live Online Training
State-of-the-art 100% Visual Inspection
6-8 October 2026
Course No. 22675
Speakers
Dr Helmut Gaus
ECA Visual Inspection Group
Dr Daniel Müller
GMP Inspector
Dr Stephen Langille
formerly FDA
Felix Krumbein
Head ECA Visual Inspection Group
Martin Dearden
ECA Visual Inspection Group
Christof Langer
OSConsulting
Sebastian Mayer
Heuft Systemtechnik
Haluk Dönmez
B. Braun
Dr Max Scheible
Vetter Pharma-Fertigung
Highlights
- Compliance with EU & US GMPs and Pharmacopoeias - Manual and Automated Visual Inspection – including Usage of AI - Organisation, Implementation and Qualification of Visual Inspection
Target Group
This course is directed at staff from sterile operations involved in the 100% inspection process, i.e. in production, quality and engineering. Suppliers of primary packaging materials and inspection technology are also part of the target group for this event.
Objectives
Pre-Conference Course: Fundamentals of Visual Inspection 6 October 2026
The training course on visual inspection which takes place before the Conference gives you an understanding of the fundamentals of visual inspection of injectable products, applicable to manual and automated inspection. You will also learn how to implement an automated system based on manual inspection and how to qualify it
Skills you will develop through the course:
Ensuring GMP-compliance in manual inspection
Setting up a qualification strategy for automated systems
GMP-compliant routine operation of automated systems
Conference: Visual Inspection of Parenterals 7/8 October 2026
This conference provides a comprehensive overview of the detection and evaluation of visible particles in injectable products, covering current regulatory expectations in the US and Europe as well as practical implementation in routine manufacturing. It addresses both manual and automated inspection, including validation, training, defect classification, AQL testing, trending and re-testing strategies.
Participants will gain clarity on evolving compendial requirements (USP <790>, <1790>, Ph. Eur. 5.17.2, EU Annex 1) and learn how to select, qualify and operate automated inspection systems, including the use of artificial intelligence. Practical challenges such as root cause analysis, reduction of false rejects, inspection of difficult container types and process transfer between sites will also be discussed.
Programme
Pre-Conference Course: Fundamentals of Visual Inspection
6 October 2026
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?
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 the 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 the evaluation of visual defect criticality, particle source, and patient impact
Particulate Matter: Origins and Root Cause Analysis
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 standardisation 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
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 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 / pre-trained models, labelling application
Documentation of model development: traceability, risk minimisation and build-up of confidence
Multi-Colour 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.
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
ECA Guide on Visual Inspection of Parenterals
All participants receive the current version of ECA’s Guide on “Visual Inspection of Medicinal Products for Parenteral Use” for free.
Fees Conference (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
Fees Pre-Conference Workshop (per delegate, plus VAT) ECA Members EUR 1,090 APIC Members EUR 1,190 Non-ECA Members EUR 1,2090 EU GMP Inspectorates EUR 645 The conference fee is payable in advance upon receipt of invoice.
You save 400 EUR for booking pre-conference course and conference together.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
