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2020 Visual Inspection

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

Apr 28 - Apr 29, 2022
Berlin, Germany

  • Education
  • Europe

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Program Highlights

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

 

Overview

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.

Agenda

  • Day 1
  • Day 2
  • Thursday, 28 April 2022

    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

  • Friday, 29 April 2022

    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

Trainers

Markus Lankers
Markus Lankers
MIBIC GmbH & Co KG
John G. Shabushnig
John G. Shabushnig
Insight Pharma Consulting, LLC

Additional Information

  • Learning Objectives

    Learning Objectives

    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
  • Who Should Attend

    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

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Travel

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.

Dorint Kurfürstendamm Berlin

Augsburger Strasse 41
Berlin, Germany

Dorint Kurfürstendamm Berlin
  • Accommodations

    The general terms of business are valid at the event hotels.


    Dorint Kurfürstendamm Berlin
    Augsburger Strasse 41
    10789 Berlin
    Germany
    Tel: +49 30 800999-0

    Just 100 m from the Kurfürstendamm boulevard, the life-style hotel Dorint Kurfürstendamm Berlin is characterized by elegance and understatement, it offers air-conditioned rooms, free WiFi and a French restaurant. Guests have free use of the spa and gym.

  • Amenities

How to Get Here

By Air

Berlin's airport Berlin Brandenburg International (BBI) is situated approximately 28km from the hotel. Train and tram connections are available.

By Car

Self-parking on site (EUR 27,00 per night).

Other Options

  • The nearest train station ‘Zoologischer Garten’ is a 7 minutes walk away.
  • The metro station ‘Kurfürstendamm’ is a 2 minutes walk away.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.795

All fees given in Euro and excluding VAT

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Tel: +49 (0) 30 43 655 08-10

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