PDA EU00009 An Introduction to Visual Inspection: A hands-on course

Berlin, Germany
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Program Highlights

The training course covers the fundamentals of visual inspection methods and their application to injectable products.

 

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
Event Location
INNSiDE by Meliá Berlin Mitte
Chausseestraße 33, Berlin, Germany Get Directions

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
Christopher Haertig
[email protected]
Registration Customer Care

Standard Pricing

Standard Member Price

€1.895

GovernmentMember Only

€1.895

Health AuthorityMember Only

€1.895

Early Career ProfessionalMember Only

€1.895

StudentMember Only

€1.895

AcademicMember Only

€1.895

Non-Member

€1.895

See Qualifying Criteria for Member Types.

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, 15 November 2023

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

Day 2

Thursday, 16 November 2023

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 Training Course

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 33
Berlin, Germany , Germany
Make a Reservation Online

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 1st October 2023.

Book your room at the PDA Group Rate via the above-mentioned reservation button.

How to Get Here
By Air BER Airport is 8,7 km away from the hotel.