PDA How to Handle Test Sets in Visual Inspection Training Course
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Visual inspection test sets are essential for operator qualification and validation of a visual inspection systems to be compliant with all pharma regulations, GMP requirements, and company specific quality standards.
As test sets are individually designed and developed based on the product specifications as well as the manufacturing processes, no “one-size fits all” solution is possible. Its variability regarding size, content, and purpose makes management along the life cycle of a test set even more difficult. Starting from the creation of a test set to the vision evaluation up to the correct application along the manufacturing process reflects the high level of complexity.
This training course will take place at the Körber Pharma Inspection Site in Dublin, Ireland. In order to fully understand the “why do I need”, “when do I need”, “what do I need” combined with “how do I create”, “how do I apply”, and “how do I manage” a test set, experts will share their expertise based on best practices and years of experiences within the pharmaceutical industry.
Learning Objectives
- Understanding compliant VI test set design, qualification, and lifecycle management: purposes, process, and applications
- Understanding the current regulatory expectations and quality risk management of VI and particle control
- Understanding the different types of defects and their potential impact on quality
- How to develop a test kit for the visual inspection (risk analysis, what defects should be included)
- How to build up a test kit for the visual inspection (practical introduction)
- How to handle a test kit (shelf life, storage and more)
- Hands on experience on manual & automatic inspection
- The importance of a defect sample set for an AVI project
- How to handle DIP on AVI
Program Highlights
This two-day training course will take place at Körber Pharma Inspection in Dublin, Ireland.
Highlighted Trainers
Key Presenters
Agenda
Discover What's Happening Each Day
(Note: The file may take a moment to download depending on your connection.)
BST Daylight Time (UTC +1:00)
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Welcome, Introduction, and Collecting Participants' Expectations
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1.1 Introduction to Test Sets for Visual Inspection (MVI, SAVI, and AVI) – Current Regulatory Requirements and Best Practices
- Overview of the agenda and goals of the training course
- VI Test sets – purpose, usage, and requirements
- Current regulatory requirements to VI & VI test sets
- Regional differences, terminology, and defect classification
- Examples from recent FDA 483s and Warning Letters
- MVI operator training and qualification, AVI qualification/ validation, transition from MVI to SAVI/ AVI, daily functional checks
Probabilistic nature of visual inspection - statistical methodology, Knapp approach, Probabilities of detection (PoD), false rejects
- The VI qualification journey (MVI/ SAVI/ AVI) - Test set design, manufacturing, creation, qualification, and usage (a process flowchart)
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Coffee Break
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1.2 Fundamentals of Test Set Design
- Risk assessment – why is it needed and how to carry it out?
- Defect libraries
- Considerations for test set design
- Primary packaging
- Product attributes
- Types and sizes of defects
- Additional considerations
- Test set size; defect-containing and defect-free units
- Types of defects
- Defect Categories
- Major
- Minor
- Critical
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1.3 Practical Considerations for Use and Creation of VI Test Sets Defects
- Particles
- Spherical particles
- Irregular particles
- Particle behavior (e.g., adhering vs. floating particles)
- Other defects
- Container defects
- Glass (Cracks, Scratches, Leaking)
- Stopper defects
- Cap defects or crimping defects
- Contaminations (inside-outside)
- Product defects - discoloration, turbidity, fill defects, etc.
- Container defects
- Distinction of test sets required for visual inspection from test sets required for CCI testing
- Particles
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Lunch Break
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1.4 Introduction to Test Sets for Automated Visual Inspection
- How to handle test sets during a project?
- Test set for validation of automated visual inspection machine, including AVI development test set
- Test set for daily performance check of automated visual inspection machine
- Knapp test set
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1.5 Requirements Related to Automated Visual Inspection
- Transformation of the main principles from manual visual inspection to automated visual inspection
- Challenges in the manual inspection
- Transition to the automation
- Advantages of the automated inspection
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1.6 Practical Exercise – Test set design
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Coffee Break
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1.7 Vision Evaluation Done Right: Test Sets, Steps, Results
- How to handle the test set in a vision evaluation
- Step-by-step explanation of the evaluation process and what's important
- Evaluation Result and how to proceed with the results in the further process
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Wrap-up Training Course Day 1
- Questionnaire
- Q&A for all questions on training course day 1 (if not yet answered)
- Feedback session
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End of Training Day 1
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Dinner
BST Daylight Time (UTC +1:00)
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What Are Your Practical Challenges with Test Sets?
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1.8 Test Sets for Difficult to Inspect Products (DIPs)
- General considerations for defect detectability and additional regulatory requirements
- Types of DIP
- Lyophilized products
- ATMPs
- Colored glass containers
- Emulsions
- Suspensions
- Turbid liquids
- Surrogate solutions versus product
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1.9 Discussion on Technical Challenges with Difficult-to-Inspect Products – Test Set Manufacturing, MVI, and AVI-Specific Challenges
- Small-volume and large-volume containers
- Lyophilized products Infusion bags
- BFS containers
- Highly turbid products
- Colored solutions and containers
- Highly viscous products
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Coffee Break
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2.0 Test Set Challenges = (Pharma Perspective, Test Set Manufacturer’s Perspective, AVI System Supplier’s Perspective)
- Product-specific vs bracketing approaches
- Special containers
- MVI vs AVI
- False Reject Rates
- Challenging defects
- Air bubbles
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Lunch Break
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2.1 Virtual Facility Tour at Körber Pharma Inspection Site
- Operational Walkthrough
- Close-Up Views
- Automatic sample sorting
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2.2 Lifecycle Management of Test Sets
- Required data and documentation:
- Certificate of manufacturing (expected characterization data)
- Qualification report
- Training certificates
- Inspector re-qualification (different approaches)
- Lifecycle management:
- Storage and shelf-life, provisional shelf-life setting
- "Disappearing“ defects
- Replacement of units
- Re-qualification of test sets
- Multi-site setup (same product, different facilities) - harmonization of practices, benchmarking
- Phase-appropriate approaches:
- Early phase vs. BLA and commercial
- Product-specific vs. bracketing approaches
- Required data and documentation:
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Coffee Break
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Wrap-up Training Course Day 2
- Knowledge check - multiple choice test
- Q&A training course day 2
- Review results from practical exercise Day 1 – additional considerations/ modifications
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End of Training Course
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Körber Pharma
GEC Taylors LaneDublin, Ireland D08 YCK6 Ireland
PDA recommends the reservation at the following hotels:
Ashling Hotel
10-13 Parkgate Street
Dublin 8 D08 P38N
Ireland
Hyatt Centric
Dean Street
Dublin D08 W3X7
Ireland
Registration
Pricing Options
Standard Registration
Member Price
€2,200Non-Member
€2,350
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
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