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Parenteral Drug Association Connecting People, Science and Regulation ®

An Introduction to Visual Inspection: A hands-on course

Sep 28 - Sep 29, 2017 |
Sep 29, 2017 |
Sofitel Berlin Kurfürstendamm | 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, PhD Managing Director, rap.ID Particle Systems GmbH
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.


Thursday, 28 September 2017

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

Friday, 29 September 2017

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 Size
    • 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

4 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

1495 Euro

All fees given in Euro and excluding VAT (7%)

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

Sofitel Berlin Kurfürstendamm
Augsburger Strasse 41
10789 Berlin
Germany
Tel: +49 30 800 999 0
Fax: +49 30 800 999 99
Hotel Website
Email

Just 100m from the Kurfürstendamm Boulevard, Sofitel Berlin Kurfürstendamm has a strikingly modern architecture with its spacious rooms and suites featuring dark woods and high windows.

Restaurant Le Faubourg offers traditional French cuisine and an outdoor terrace overlooking Kurfürstendamm.

Formerly the Hotel Concorde Berlin, the Sofitel Berlin Kurfürstendamm provides a touch of luxury in an Art Deco building. It is near designer boutiques, cultural highlights, the KaDeWe department store, Berlin Zoo, the Theater des Westens, Charlottenburg Palace and the Deutsche Oper Opera House.

Kurfürstendamm Underground Station is just a 3-minute walk from the Sofitel. Buses run directly to Tegel Airport from there.

PDA Europe has reserved a limited number of rooms until the 17th August 2017.

for the PDA Group Rate.

Single Room € 165 per night*
Double Room € 185 per night*

*Rates are per room and night, including the following services and benefits:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (Wi-Fi)
  • On-site Parking
  • Taxes and Service will apply

How to Get There

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel distance: 13 km

  • Bus service, fee: € 2.80 (one way)
  • Estimated taxi fare: € 26

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 6091 1150
Hotel distance: 23 km

  • Bus service, fee: € 3.40 (one way)
  • Estimated taxi fare: € 48

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=3370

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