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

Munich, Germany
Ask a Question Exhibitor Standard Contract Clause
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.

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
Event Location
H4 HOTEL MÜNCHEN MESSE
Konrad-Zuse-Platz 14, Munich, Germany Get Directions

Contact

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

Standard Pricing

Standard Member Price

€ 2.090

Non-Member

€ 2.090

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

Thursday, 11 April 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

Day 2

Friday, 12 April 2024

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
Agenda is subject to change.

Featured Trainers

  • Markus Lankers, PhD

    MIBIC GmbH & Co KG

    Read Bio

  • John G Shabushnig, PhD

    Principal Consultant, Insight Pharma Consulting, LLC

    Read Bio

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.

H4 HOTEL MÜNCHEN MESSE

Konrad-Zuse-Platz 14
Munich, Germany , Germany
Make a Reservation Online

PDA Europe has reserved a limited number of rooms by 12 February 2024.
Please be aware that those rooms are limited to that rate due to a city fair.

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

How to Get Here
By Air Take the S8 (direction Herrsching) from the airport to the Daglfing station and go from there for about 3 minutes to the bus stop Daglfing station east. Ride the bus 183 until Paul-Henri-Spaak-Straße stop. The hotel is 100 meters away from the Paul-Henri-Spaak-Straße stop. Unlock discounted pricing with the following code DEAPILQ and simply use the provided link below.
Book Discounted Flights
By Car From the North : Drive on the A9, keep on the right, follow the signs to Salzburg / Österreich / Italien / Innsbruck and continue on the A99. At the exit München-Ost, keep on the right and take the A94 towards Munich. After approximately 6 km you exit the motorway at junction München-Riem and head left on the street “An der Point”, which changes into “Olof-Palme-Straße” after the second traffic light. The H4 Hotel München Messe is located on the right hand side after 500 m. The parking garage can be reached through the back of the hotel (Graf-zu-Castell-Straße). From the South: Drive on the A8 and at junction München-Süd continue on the A99 and follow the signs for Nürnberg / Stuttgart / Messe / München Flughafen. Change at junction München-Ost to the A94 and follow the signs to Munich. After approximately 6 km you exit the motorway at junction München-Riem and head left on the street “An der Point”, which changes into “Olof-Palme-Straße” after the second traffic light. The H4 Hotel München Messe is located on the right-hand side after 500 m. The parking garage can be reached through the back of the hotel (Graf-zu-Castell-Straße).
By Other Options By Train: You can reach us by underground line 2 (towards Messestadt Ost, exit at Messestadt West). Or use the S-Bahn line 2 (towards Erding, exit at Riem) and afterwards take bus 190 (towards Messestadt Ost, exit at Am Messesee). Unlock discounted pricing and simply use the provided link below.
Book Discounted Trains