An Introduction to Visual Inspection: A hands-on course
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Program Highlights
Note COVID-19 situation up-date 30th March 2020:
PDA is closely monitoring the Corona virus situation. Travel restrictions have been widely implemented in European countries and globally in the last couple of days which will prevent our members, volunteers, presenters, attendees and exhibitors from attending the Visual Inspection Forum and the associated training courses, planned for 21-24 April 2020 in Berlin, Germany.
We consider the safety and health of attendees and staff as subject of utmost importance. Taking all factors into consideration, PDA Europe has decided to postpone the Training Course An Introduction to Visual Inspection: A hands-on course to 21-22 October 2020. The course will take place at the Steigenberger Hotel, Berlin. For detailed information, please visit the updated event site.
Your registration will be transferred to the new date and we hope to retain your full participation. Please know you will have the ability to request a credit or full refund if you find you are not able to attend the event at its revised date.
We recognize the challenge this may cause, and we do apologize for the inconvenience.
If you have any immediate questions or requests, please contact [email protected]. Additionally, you may visit the PDA official statement on our website.
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
Wednesday, 23 April 2020
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
Thursday, 24 April 2020
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.
Just 800 m from the Brandenburg Gate, Steigenberger Hotel am Kanzleramt is located directly beside the German Parliament buildings in Berlin. Free Wi-Fi access is available. Each of the air-conditioned rooms here at Steigenberger Hotel am Kanzleramt will provide you with a minibar, tea/coffee facilities and a flat-screen TV. Private bathrooms come with bathrobes and slippers. Rooms are decorated in a modern style.
At Steigenberger Hotel am Kanzleramt you will find a 24-hour front desk, a bar and an a restaurant. Other facilities offered include a ticket service and luggage storage. The hotel is 3 km from Alexanderplatz, 4 km from Kurfürstendamm and a 25-minute walk from Potsdamer Platz.
You can book your Hotel Accomodation here!
PDA Europe has reserved a limited number of rooms until the 25th February 2020
Single Superior Room 159.00€ per night*
Double Superior Room 179.00€ per night*
*Rates are per room and night, including the following services and benefits:
- Buffet Breakfast in the restaurant
- Wireless Internet Connection (WI-FI)
- VAT, Taxes and Service Charge will apply