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

Nov 09 - Nov 10, 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.

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Agenda

  • Day 1
  • Day 2

  • Wednesday, 09 November 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

  • Thursday, 10 November 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
Bio
Markus Lankers
MIBIC GmbH & Co KG

Markus is one of the co-founders of MIBIC GmbH that develops rapid bacteria identification systems. Within MIBIC Markus is responsible for research and development of new spectroscopic methods for bacteria analysis. He has 25 years of experience in the field of particle identification. In 2002 he founded rap.ID Particle Systems GmbH and served as Managing Director until the sale of the company in 2018. Prior to this position, he worked as a scientist in different development departments at Schering AG, Berlin, Germany.

Markus holds a diploma in Chemistry and a Ph.D. in Physical Chemistry from the University of Würzburg. He is an active member of the Parenteral Drug Association (PDA). Since 2003, he has supported the ‘Visual Inspection of Parenterals’ Interest Group in Europe as Interest Group Leader.

He has served as program co-chair for the PDA Visual Inspection Forum from 2001 to 2018 in Europe and the U.S.
John G. Shabushnig
John G. Shabushnig
Insight Pharma Consulting, LLC
Bio
John G. Shabushnig
Insight Pharma Consulting, LLC

John is the founder of Insight Pharma Consulting and is an expert in visual inspection.  He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations.  He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection.  He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology.

John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University.  He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board.  He organized and leads the Visual Inspection Interest Group.  He is also an instructor at PDA's Training and Research Institute.  John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel.  He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods and visual inspection.  He is a co-author of the recently published book Visual Inspection and Particulate Control.

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

    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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Berlin, Germany

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All Participants €1.795

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