PDA EU00134 Mastering Automated Visual Inspection
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Visual Inspection mastery is fundamental in parenteral manufacturing in order to guarantee both patient safety and cost effective supply. The capability of Automated Visual Inspection (AVI) has progressed extensively over the years to the point where, when applied appropriately, it can offer significant advantages over manual and semi-automated inspection processes. This has been made possible thanks to major innovations and technology breakthroughs. In line with these technological advances, the regulatory requirements for this challenging process have been reinforced. As a consequence, AVI machines today are complex and require multidisciplinary project teams for successful implementation.
Who Should Attend
This course is designed specifically for those who are involved or interested in moving from manual to automated inspection like
- Managers, Supervisors and all Decision makers in the visual inspection area
- Quality personnel
- Prerequisites: Basic understanding and practical experience of manual inspection (as conveyed in the PDA course ‘Introduction to Visual Inspection’)
Learning Objectives
Upon completion of this course, attendees will be able to:
- Acquire basics about regulatory landscape for AVI
- Be ready to design your URS
- Understand key functions of AVI equipment
- Define your defect kits and validation strategy
- Develop your own control strategy around AVI
- Test normality at a glance, interpret, and communicate the results
- Have basic knowledge about computer vision
Program Highlights
Taking place from 04-05 December 2024, PDA Europe offers participants an exciting opportunity to develop and refine their practical skills. Various topics related to visual inspection will be covered by leading industry experts in this training course.
Highlighted Trainers
Key Presenters
Agenda
Discover What's Happening Each Day
Wednesday, 04 December 2024
9:00
Welcome & Introduction
9:30
Theory 1: Introduction To Regulatory Requirements of Visual Inspection
- USP 1, USP 788 and 1788, USP 790 and 1790
- PhEur e.g. 2.9.20 • JP e.g. 6.06
- Annex 1
- Similarities and differences in compendial methods
- 100% inspection and AQL testing
- Definitions and practical examples of inherent, intrinsic, and extrinsic particles
- Findings from audits
10:45
Coffee Break
11:15
Theory 2: Introduction Into Technical Principles of Automated Inspection Machines
- Functionality of automated inspection machines
- Camera systems/light /motion
- Image processing and database system
- Interlinkage of parameters: Speed, Rotation speed, Inspection parameters, Detection probability, False reject rate
- Properties, capabilities, and limitations of automated inspection systems
- Scope of Automated Visual Inspection
- Leak testing principles
12:15
Lunch Break
13:15
Theory 2: Introduction Into Technical Principles of Automated Inspection Machines (cont.)
14:15
Theory 3: Considerations on Primary Containers and Product Properties
- Vials, Ampoules, Syringes, Blow – Fill - Seal, Viscous liquids, Air bubbles/scratches, Refrigerated product containers
- Product impact study
14:45
Exercise 1: Developing Risk Assessment Based on URS
15:45
Coffee Break
16:15
Theory 4: Selection and Purchasing of an Automated Inspection System
- Technical requirements
- Integration into existing processes, lines/ machines, and systems
- Cost and effort considerations
- Risk Assessment
17:15
Exercise 1 (cont.): Presentation of the Results of the Sub-Groups and Discussion of the Results
17:30
Q&A
17:45
End of Training Course Day 1
Thursday, 05 December 2024
9:00
Recap of Day 1
9:15
Theory 5: Transition from Manual Inspection to Automated Inspection
- Manual inspection as a prerequisite for transition to automated inspection
- Interpretation of inspection results and validation data
- Considerations on validation program for automated inspection
- Performance measurement
- Maintaining the manual inspection
- Knapp Principle/Fixed criteria
10:15
Exercise 2: Principle Basic Image Processing Using an Open Source Library and Commercial Library
11:00
Coffee Break
11:15
Exercise 2 (cont.): Presentation of the Results
12:00
Theory 6: Qualification Test Set and Routine Test Set
- Statistical considerations on the number of objects containing defects
- Particle selection, particle size, and size uniformity
- Labeling of test set objects
- Supply/purchase of test sets
- Maintaining and lifecycle of test sets
- Sampling from rejects
- Defect master library
- Types of defects
- Quality requirements
13:00
Lunch Break
14:00
Theory 7: Visual Inspection Lifecycle and Control Strategy
- Integration of visual inspection into the overall manufacturing process
- Elements of lifecycle
- Particle identification/characterization
- Defect libraries as dynamic database
- AQL sampling principle
- Control Charting
15:00
Theory 8: Operation and Maintenance of Automated Inspection Systems
- Spare part list
- Predictive maintenance
- First-line maintenance
- Calibration
15:30
Coffee Break
16:00
Theory 9: Future Trend of Automated Visual Inspection
- Moving toward deep learning
16:15
Wrap-up Training Course
- Evaluation
- Q&A Discussion
16:30
End of Training Course
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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.
PDA recommends the reservation at the following hotel
INNSide by Meliá Berlin Mitte
Chausseestraße 33
10115 Berlin,
Germany
PDA Europe has reserved a limited number of rooms until 21 October 2024.
Book your room at the PDA Group Rate using the above-mentioned reservation button.
How to Get Here
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Event Ticket one-way and specific train (subject to availability):
- 1st class 89,90€ (seat reservation incl.)
- 2nd class 55,90€
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- 2nd class 77,90€
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Member Price
€2,090Non-Member
€2,090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
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