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2020 Visual Inspection

An Introduction to Visual Inspection: A hands-on course

Apr 23 - Apr 24, 2020
Berlin, Germany

Welcome to the 2019 Visual Inspection Week! The training course covers the fundamentals of visual inspection methods and their application to injectable products.

  • Education
  • Europe

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Program Highlights

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
  • 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

  • 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

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
  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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.

Steigenberger Hotel Am Kanzleramt

Ella-Trebe-Straße 5
Berlin, Germany
Phone: +49 30 740743-0

Steigenberger Hotel Am Kanzleramt
  • Accommodations

    Hotel Website

    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.

    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
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
5.6 mi (7,9 km), 18 min by car
Limousine service: € 65 (one way)
Estimated taxi rate: € 30 (one way)

OR

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 to take zhe S-train 9 and get off at Berlin Hauptbahnhof.

By Car

The Hotel is located outside of Berlin main train station

Other Options

Berlin Central Station: Right outside of the main train station, in sight of the Federal Chancellery, you will find the Steigenberger Hotel Am Kanzleramt.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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