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Visual Inspection Forum

On the Path from MVI to AVI - Challenges and Trends
Oct 23 - Oct 24, 2018 |
Oct 24, 2018 |
Berlin Mariott Hotel | Berlin, Germany
  • Conference
  • Europe
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Dear Colleagues,
On behalf of the Scientific Program Planning Committee, we would like to invite you to submit a paper or poster abstract for a presentation at the Visual Inspection Forum held in Berlin / Germany, 23-24 October 2018.

The forum will provide a platform to present and discuss new developments in the field of visual inspection, including a basic understanding of the sampling and inspection process, special aspects of biotech products, practical aspects of manual, semiautomated and automated methods and the regulatory and compendia requirements that govern them.

On 20 December 2017, the long-awaited Annex 1 Revision of the EU GMP Guidelines was finally published. While the currently valid Annex 1 only briefly touches on the important topics of container closure integrity control and visual inspection, this amendment offers a number of innovations. The new requirements encourage further discussion of the correct understanding and implementation in visual inspection and provide only one of this year‘s hot topics to be discussed.

Are you are currently working in Visual Inspection? Do you have insight into the regulatory landscape? Are you developing an innovative concept in research?

We warmly invite you to share your know-how, specific case studies or new data with our distinguished audience.
We look forward to seeing you take part in the Visual Inspection Forum 2018!
Sincerely,

John Shabushnig, PhD,
Insight Pharma Consulting, Chair

Markus Lankers, PhD,
Consultant, Chair

Download Call for Papers

Submit Abstract

Tuesday, 23 October 2018

9:00
Welcome and Introduction
Falk Klar, PDA Europe
Markus Lankers, Consultant, Chair
John Shabushnig, Insight Pharma Consulting, Chair

9:15 - 12:30
Session 1: Regulatory Landscape and Updates
Moderator: Markus Lankers, Consultant

9:15
Speaker invited

9:45
Proposed Changes to the EU GMP Annex 1 and a Comparison with Corresponding USP Chapters
John Shabushnig, Insight Pharma Consulting

10:15 – 10:45
Coffee Break, Poster Session & Exhibition

10:45
Container Closure Integrity Testing –The Impact of the Annex 1 Revision
Derek Duncan, LIGHTHOUSE

11:15
Visible Particle Requirements in the European Pharmacopeia
Hanns-Christian Mahler, LONZA

11:45
Q&A, Discussion

12:30 – 13:30
Lunch Break, Poster Session & Exhibition

Transition Parallel Tracks

13:30 - 15:30
Session 2A:Deep Learning and Artificial Intelligence
Moderator: Heino Prinz,Rommelag

13:30
From MVI to Deep Learning
Romain Veillon, GSK Vaccines

14:00
Application of Artificial Intelligence, Machine Learning and Deep Learning to the Pharmaceutical Automatic Inspection Processes
Massimo Frasson,Brevetti

14:30
Improvements on Empty Glass Quality Inspection Using Deep Learning Algorithms
Massimo Mozzi,SPAMI

15:00
Q&A, Discussion

13:30 - 15:30
Session 2B:Control Strategies
Moderator: John Ayres, Pharma Safety Solutions

13:30
Statistically Valid Sampling Plans for Automated Inspection Qualification and Routine Operation
Gabriel Anderson,Novartis

14:00
Visual Inspection in the Context of an Overarching Control Strategy
Elizabeth Zybczynski ,Baxter Healthcare

14:30
Implementation of Zero Tolerance for Injectable Products
Montse Domínguez Fernández ,Boehringer Ingelheim

15:00
Q&A, Discussion

15:30 – 16:00
Coffee Break, Poster Session & Exhibition

16:00 - 18:00
Session 3: Particle Identification and Supplemental Testing
Moderator: Renaud Janssen,Datwyler

16:00
Analysis of Particulate Matter in Liquid Finished Dosage
Balazs Havasi, Novartis

16:30
Introducing the PDA/PMF Zero Visible Particles Project
Maurizio Fantozzi, Stevanato Group

17:00
Visual Inspection of Single-Use Systems for Biopharmaceutical Processing
Klaus Wormuth, Sartorius Stedim

17:30
Identification of Micro Steel Particles using Energy Dispersive X-ray Spectroscopy coupled with Multivariate Statistics
Jonas Hoeg Thygesen, Novo Nordisk

18:00
End of Conference Day 1

18:30
Networking Dinner

Wednesday, 24 October 2018

9:00
Welcome and Introduction
Markus Lankers, Consultant, Chair
John Shabushnig, Insight Pharma Consulting, Chair

9:10 - 12:30
Session 4: Difficult to Inspect Products
Moderator: Romain Veillon, GSK

9:10
Introducing the new PDA Technical Report TR-79 on Particulate Matter in Difficult to Inspect Parenteral Products
Roy Cherris, Bridge Associates

9:40
An Update on Difficult to Inspect Products, other Physical Characteristics, and Process Related Phenomena Which Equally Influence (Automatic) Inspectability
Søren C Meyer, InnoScan

10:10
Effect of Visual Inspection Parameters on the Inspection Effectiveness for Flexible Containers
Neal Zupec, Baxter Healthcare

10:40 – 11:10
Coffee Break, Poster Session & Exhibition

11:10
Spectral Coded Illumination for Reliable Differentiation Between Transparent Particles and Air Bubbles.
Christian Scherer, Seidenader Maschinenbau

11:40
Data Driven Control Strategy for Flexible (IV) Containers
Frank Dudzik, Baxter Healthcare

12:20
Q&A, Discussion

12:30 – 13:30
Lunch Break, Poster Session & Exhibition

13:30 - 15:00
Session 5: General Inspection Techniques
Moderator: John Shabushnig, Insight Pharma Consulting

13:30
Pulsed X-Ray Particles Inspection for Lyophilisates
Stephan Bachmeier, Heuft

14:00
Advanced Technologies for Automated Visual Inspection of Syringes
Jose Zanardi, Bosch Packaging Technology

14:30
Practical Approach to the Preparation of Defect Standards and Test Sets
Jean Malthete, GSK Vaccines

15:00 – 15:30
Coffee Break, Poster Session & Exhibition

15:30 - 16:30
Closing Plenary: Manufacturing and its Clinical Relevance
Moderator: Andrea Sardella, OMPI

15:30
Filtration of IV Drugs
Markus Lankers, Consultant

16:00
Medical Impact of Particles
John Ayres, Eli Lilly

16:20
Q&A, Discussion

16:30
Closing Remarks & Farewell
Falk Klar, PDA Europe
Markus Lankers, Consultant,
John Shabushnig, Insight Pharma Consulting,

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).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 2 September 2018
1.395 Euro

After 2 September 2018
1.595 Euro

Nonmember

By 2 September 2018
1.695 Euro

After 2 September 2018
1.895 Euro

Govern./Health Authority/Academic

By 2 September 2018
700 Euro

After 2 September 2018
800 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
Email

Exterior

Berlin Marriott Hotel
Inge-Beisheim-Platz 1
10785 Berlin
Germany
Tel: +49-30-220000
Hotel Website

Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

PDA Europe has reserved a limited number of rooms until the 21st August 2018.
Book Your Room for the PDA Group Rate

Single Room € 195 per night*
Double Room € 215 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service Charge will apply

How to Get There

Berlin-Tegel Airport – TXL
Airport Phone: +49 30 60911150
Hotel direction: 5.6 miles SE

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 60911150
Hotel direction: 12.3 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 3.5 EUR hourly, 30 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=4161

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