PDA EU00009 An Introduction to Visual Inspection: A hands-on course
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This training course covers the fundamentals of visual inspection methods and their application to injectable products. The detection and identification of visible particles is a key part of the course content, though container and closure defects are discussed as well. Students combine classroom review of current regulatory requirements and inspection methods with hands-on laboratory exercises to develop and practice practical inspection skills. The skills developed through this combination of classroom and laboratory exercises may be applied to manual human inspection, semi-automated and automated machine inspection methods. This is also an excellent opportunity to discuss your specific inspection questions and; challenges with expert instructors.
Who Should Attend
This course is designed specifically for:
- Injectable Drug Product Manufacturing Professionals and Management
- Quality Professionals and Management
- Validation and Manufacturing Engineers
- Technical Support Staff
- Product Development Scientists
- Inspection Equipment Manufacturers
Learning Objectives
Upon completion of this course, attendees will be able to:
- Understand current global regulatory and compendial requirements for visual inspection
- Understand patient risk associated with visible particles in injections
- Implement a technically sound and compliant inspection process
- Assess inspection performance
Program Highlights
The training course covers the fundamentals of visual inspection methods and their application to injectable products.
Agenda
Discover What's Happening Each Day
Wednesday, 04 December 2024
9:00
Welcome and Introduction
- Why We Inspect
- Patient Safety
- Regulatory Requirements
- Compendial Requirements
10:30
Coffee Break
11:00
Inspection Methods and Technologies
- Critical Parameters (lighting, time, contrast and motion)
- Manual Visual Inspection (MVI)
- Semi-Automated Visual Inspection (SAVI)
- Automated Visual Inspection (AVI)
12:30
Lunch Break
13:30
Particle Identification
14:30
Laboratory Exercise: Manual Visual Inspection
- Light Measurement
- Assessment effect of changing critical Variables
- Time (10 sec vs. 20 sec)
- Lighting (2,500 lux vs. 1,250 lux)
- Motion/Agitation (with vs. without)
15:30
Coffee Break
16:00
Continue Laboratory Exercise
17:30
Wrap-up Discussion / Q&A
18:00
End of Training Course Day 1
Thursday, 05 December 2024
9:00
Inspection Data Review
- From the previous day’s laboratory exercise
10:00
Defect Classification Strategies
- Risk classification definitions
- Critical, Major, and Minor defects
10:30
Coffee Break
11:00
Acceptance Sampling
- Sampling Plan Variables
- Sample SizeTime
- AQL and UQL
- Common Standards
- ANSI/ASQ Z1.4
- ISO 2859
12:00
Inspector Selection and Qualification
- Vision Screening
- Initial Training
- Initial Qualification
- Requalification
12:30
Lunch Break
13:30
Inspection Strategies
- Reinspection
- 2-Stage Inspection
- Focused inspection
- Empty Vial Inspection
14:00
Inspection Validation
- Inspection performance Assessment
- Knapp Method
- Acceptance Criteria
14:30
Coffee Break
15:00
Mythbusting
- Common misperceptions in visual inspection
15:30
Wrap-up Discussion / Q&A
16:30
End of Training Course
PDA EU00134 Mastering Automated Visual Inspection
04 Dec - 05 DecPromotions and Press
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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.
INNSiDE by Meliá Berlin Mitte
Chausseestraße 33Berlin, Germany 10115 Germany
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
Special Deutsche Bahn Train Fares
Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.
Event Ticket one-way and specific train (subject to availability):
- 1st class 89,90€ (seat reservation incl.)
- 2nd class 55,90€
Event Ticket one-way and fully flexible:
- 1st class 112,90€ (seat reservation incl.)
- 2nd class 77,90€
Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.
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Pricing Options
Standard Registration
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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We're currently finalizing our list of sponsors and will share the details shortly.
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