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Parenteral Drug Association Connecting People, Science and Regulation ®

VISUAL INSPECTION WEEK: An Introduction to Visual Inspection: A hands-on course

May 22 - May 23, 2019 |
May 23, 2019 |
Courtyard by Marriott Berlin City Center | Berlin, Germany
  • Education
  • Europe
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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.

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

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

Instructors

John G. Shabushnig, PhD Principal Consultant, Insight Pharma Consulting, LLC

John Shabushnig is the founder of Insight Pharma Consulting, providing expert guidance in all aspects of visual inspection. He has over 30 years of industry experience starting as a Research Scientist at The Upjohn Company and most recently as a member of Pfizer's Global Quality Operations, where he was responsible for providing microbiology and aseptic manufacturing technical support. 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 Parenteral Drug Association (PDA), having served on the Board of Directors (2003-2011) and as Chair (2008-2009) and is the founder and leader of the Visual Inspection Interest Group. He serves on the United States Pharmacopeia (USP) Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on the subjects of spectroscopic analysis, process analytical technology (PAT), rapid microbiological test methods and the visual inspection of pharmaceutical products.


Markus Lankers, Consultant

Markus Lankers is one of the co-founders of rap.ID Particle Systems GmbH, a company that develops, manufactures and sells rapid particle identification systems. Within rap.ID Markus is responsible for research and development of specific characterization method of particulate analysis and manages two dedicated particle characterization service labs in Germany and the US. Prior to this position, he worked as scientist in different development departments with Schering AG, Berlin, Germany. He publishes and presents work in the field of particle characterization and spectroscopic analysis. As an active member of the PDA, he has helped establish the PDA Visual Inspection Interest Group in Europe and set up the first company-independent Visual Inspection Trainings Course. He has served as program co-chair for the PDA Visual Inspection Forum in Europe and the USA.

Wednesday, 22 May 2019

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, 23 May 2019

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

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1595 Euro

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Exterior

Courtyard by Marriott Berlin City Center
Axel Springer Strasse 55
Berlin 10117
Germany
Tel: +49-30-800 928 0
Hotel Website

The Courtyard Berlin City Center is situated in the heart of the action, placing you near landmarks like Checkpoint Charlie, Potsdamer Platz, Brandenburg Gate and Alexanderplatz. You'll find it easy to relax in your modern, well-appointed hotel lodging; all of the spacious rooms showcase free high-speed Wi-Fi access, luxurious bedding, an ergonomic desk, a mini-fridge and more. Fuel up for your morning in the Mitte district with a hot breakfast buffet at Oléo Pazzo, or end your day with a delicious Mediterranean meal.

We also provide a fully equipped fitness center, a sauna and an on-site coffee house. Host a meeting or social event with us here in Berlin city center to make use of 8,342 square feet of versatile venue space, cutting-edge event technology and innovative planning and catering. Make the Courtyard Berlin City Center your destination of choice for your visit to the Mitte district.

How to Get There

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel direction: 7.1 miles SE

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 6091 1150
Hotel direction: 11.7 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 2 EUR hourly, 20 EUR daily

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4721

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