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2023 PDA_Training-1988x680

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

Nov 15 - Nov 16, 2023
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, 15 November 2023

    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

  • Thursday, 16 November 2023

    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

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 BS in Chemistry from Carroll College and a PhD 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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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.

INNSiDE by Meliá Berlin Mitte

Chausseestraße 33
Berlin, Germany

Make a Reservation
  • Accommodations

    PDA recommends the reservation at the following hotel

    INNSide by Meliá Berlin Mitte
    Chausseestraße 33
    10115 Berlin,
    Germany

    PDA Europe has reserved a limited number of rooms until 1st October 2023.

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

  • Amenities

How to Get Here

By Air

BER Airport is 8,7 km away from the hotel.

By Car

More information coming soon.

Other Options

The closest metro station "Naturkundemuseum" on line No. 6 is just 2 walking minutes away from the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.895

* 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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