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An Introduction to Visual Inspection: A hands-on course - Fall Edition

Sep 26 - Sep 27, 2019
Berlin, Germany

  • Education
  • Europe

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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.


  • Day 1
  • Day 2
  • Thursday, 26 September 2019

    Welcome and Introduction

    • Why We Inspect
    • Patient Safety
    • Regulatory Requirements
    • Compendial Requirements

    Coffee Break

    Inspection Methods and Technologies

    • Critical Parameters (lighting, time, contrast and motion)
    • Manual Visual Inspection (MVI)
    • Semi-Automated Visual Inspection (SAVI)
    • Automated Visual Inspection (AVI)

    Lunch Break

    Particle Identification

    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)

    Coffee Break

    Continue Laboratory Exercise

    Wrap-up Discussion / Q&A


    End of Day 1

  • Friday,27 September 2019

    Inspection Data Review

    • From previous day’s laboratory exercise

    Defect Classification Strategies

    • Risk classification definitions
    • Critical, Major and Minor defects

    Coffee Break

    Acceptance Sampling

    • Sampling Plan Variables
      • Sample SizeTime
      • AQL and UQL
    • Common Standards
      • ANSI/ASQ Z1.4
      • ISO 2859

    Inspector Selection and Qualification

    • Vision Screening
    • Initial Training
    • Initial Qualification
    • Requalification

    Lunch Break

    Inspection Strategies

    • Reinspection
    • 2-Stage Inspection
    • Focused inspection
    • Empty Vial Inspection

    Inspection Validation

    • Inspection performance Assessment
      • Knapp Method
    • Acceptance Criteria

    Coffee Break


    • Common misperceptions in visual inspection

    Wrap-up Discussion / Q&A

    End of Course


Markus Lankers
Markus Lankers
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
  • Why Attend

    Why Attend

    Upon completion of this course you will be able to:

    • Understand current global regulatory and compendial requirements for visual inspection
    • Understand patient risk associated with visible particles in injections
    • Implement and technically sound and compliant inspection process
    • Assess inspection performance
  • 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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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.

Berlin Marriott Hotel

Inge-Beisheim-Platz 1
Berlin, Germany
Phone: +49 (0)30-220000

Berlin Marriott Hotel
  • Accommodations

    Hotel Website

    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*

    *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
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
5.6 mi (9 km), 18 min by car
Alternate transportation: Limousinen Service; fee: 100 EUR (one way); reservation required
Estimated taxi fare: 25 EUR (one way)
Bus service, fee: 2.8 EUR (one way)
Subway service, fee: 2.8 EUR (one way)
Take the Bus X9 and get off at Zoologischer Garden, then take the subway U2 towards Pankow and get off at Potsdamer Platz.


Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 60911150
12.7 mi (20.4 km), 25 min by car
Alternate transportation: Limousinen Service; fee: 130 EUR (one way); reservation required
Estimated taxi fare: 45 EUR (one way)
Bus service, fee: 3.6 EUR (one way)
Subway service, fee: 3.6 EUR (one way)
Take the train S45 to S-Bahnhof Suedkreuz. Then change to the S-train S2 and get off at Potsdamer Platz.

By Car

The Berlin Marriott Hotel is located at Inge-Beisheim Platz 1.

Other Options

Berlin Central Station: 2.3 mi from hotel.

Train Station Berlin Friedrichstrasse: 1.1 mi from hotel.


Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

* 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.

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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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