Visual Inspection of Parenterals - Live Online Conference

Visual Inspection of Parenterals - Live Online Conference

Course No 20255

This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager". Learn more.

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Dr Martin Becker, Siegfried Hameln
Martin Dearden, ECA Visual Inspection Group
Dr Helmut Gaus, ECA Visual Inspection Group
Al Goodwin, Amgen
Felix Krumbein, Head ECA Visual Inspection Group
Christof Langer, OSConsulting
Dr Stephen Langille, formerly FDA
Dr Daniel Müller, GMP-Inspector


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, trending and batch release considerations.


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 the new 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. 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 systems.
We will address those topics during the conference and discuss and answer questions on
  • The latest compendial requirements concerning particulate matter
  • How to comply with FDA’s new guidance on Visual Inspection
  • Compliance with the (revised) EU Annex 1
  • Training and qualification of operators in the Manual inspection
  • Validation and operation of an automated inspection System
  • Reduction of false rejects in automated inspection Systems
  • Trending and monitoring of visual inspection data
  • Correct AQL testing as part of the batch release
  • Re-inspection of defect fractions
  • Usage of artificial intelligence in visual inspection

Target Group

This course is directed at staff from sterile operations, that is production, quality operations and engineering. But also suppliers of primary packaging materials and inspections Technology are target group of this Event.

Technical Requirements

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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 1 revison
  • Risk Management Considerations
FDA’s new Guidance on Visual Inspection
  • The reason for the FDA’s Visible Particulate Guidance - visual Inspection compendial requirements vs. U.S. current good manufacturing practice
  • The use of Quality Risk Management for the prevention of visible particulate contamination
  • A lifecycle approach to visible particulate contamination control
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
Manual Visual Inspection – Theory and Practical Aspects
  • Probabalistic nature of visual inspection
  • Defect categorisation
  • Differentiation of test kits for training, qualification and Routine
  • Qualification and training of personnel
  • Standardisation of working conditions in manual inspection
  • Usage of the Knapp and the modified Knapp test
Requirements, Composition, and Handling of Test-Sets
  • Definition of defect categories
  • Set-up and composition of a test set
  • Test-Sets and their use for Training, Qualification and Routine
  • Handling and release of test sets
  • Documentation
Automated Visual Inspection – from Setup to Routine Use
  • Limitations of automated inspection
  • Setting up a qualification strategy for automated Systems
  • Cross validation during the PQ phase of an automated System
  • Importance of particle detection rates
  • System-Suitability, Requalification and revalidation
  • Inspection of eject fractions
  • The Roche Inspection systems: manual, semi-automated and fully automated inspection
Case Study Amgen: Optimisation of Particle Inspection Systems – Right First Time
  • Inspection of high viscosity syringe products
  • How to achieve effectively zero false fail ejects (0.04% false fails on complex particle stations)
  • Where to use Mainstream Vision inspection and Deep Learning assisted inspection
  • Amgen’s procurement and implementation strategy for new AVI Systems
  • Take home messages for improving visual inspection systems
Re-Inspection of Defect Fractions in Visual Inspection
Different scenarios will be covered such as:
  • Re-inspection or additional inspection of “grey-channel” units from (semi-) automated inspection
  • Re-inspection in case of exceeding alert limits or AQLfailures
  • Focused re-inspection
  • Inspection approaches in case of investigations due to unexpected particles (e.g., to determine frequency of occurrence of visible particles when particles are found during release/stability testing
Particle Testing and the Correlation with Trending and Batch Release
  • Why do we Monitor (What is it all about?)
  • Data and Measurement
  • The AQL trap
  • Improvement Process Map
  • Investigation and Routine Analysis,
  • Release Process: “To AQL or not to AQL, that is the Question”
  • Product Release: “Falling off a log”

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