An Introduction to Visual Inspection: A hands-on course - Fall Edition
Registration Options
Individual Registration
Group Registration
Program Highlights
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.
Upon completion of this course, the attendee will be familiar with:
- 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
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Standard Pricing
Standard Member Price
€1.595GovernmentMember Only
€1.595
Health AuthorityMember Only
€1.595
Early Career ProfessionalMember Only
€1.595
StudentMember Only
€1.595
AcademicMember Only
€1.595
Non-Member
€1.595
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
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 [email protected] 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.
Day 1
Thursday, 26 September 2019
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 Day 1
Day 2
Friday,27 September 2019
9:00
Inspection Data Review
- From 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 Course
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Request InformationPLEASE 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.
Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.
Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.
Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.
PDA Europe has reserved a limited number of rooms until the 26th July 2019.
Book Your Room for the PDA Group Rate
Single Room € 195 per night*
Double Room € 215 per night*
- Buffet Breakfast in the restaurant
- Wireless Internet Connection (WI-FI)
- VAT, Taxes and Service Charge will apply