2023 PDA Visual Inspection Workshop

Berlin, Germany
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Dear Colleagues,

Please be kindly invited to join this one-day meeting on visual inspection (VI) that will be held in Berlin, Germany on 14 November 2023.

This workshop is organized with the help of the PDA Visual Inspection Interest Group and focus on current topics of practical interest to those responsible for VI in their companies or those who supply products or services in VI.

The focus is put on exchanges and discussions on hot topics related to visual inspection. Short expert presentations are provided to stimulate discussion followed by time for more extensive discussion, Participants can bring their relevant questions, challenges, and experience resulting in a diverse and practical discussion of each topic. This has proven very fruitful in the past and provides an opportunity to align the workshop with the specific interests of those who register and attend.

We have identified three topics for discussion this year:

  • the new EU GMP Annex 1 deployment
  • defect test kits
  • particle identification

Expert speakers include John Shabushnig, from Insight Pharma Consulting, Matthias Eisele from M.A.S., and Markus Lankers from MIBIC who will facilitate discussion on the above topics, respectively. The discussion on Annex 1 will focus on the changes in the revised annex, industry experience, and their practical implications. The discussion on test kits will cover kit design and construction and the discussion on particle identification will include how to determine the correct level of particle characterization and how to differentiate extrinsic from intrinsic particles. Inevitably, additional topics will be included as participants add to the discussion.

This is a great opportunity to network and learn from experts and colleagues who share the same interests and challenges as you. You may also want to take advance of the training course offered immediately following the Workshop in the same venue. Both An Introduction to Visual Inspection: A hands-on course and Mastering Automated Visual Inspection will be taught on the days following the workshop in the same venue.

We look forward to welcoming you in Berlin this fall!

Sincerely,
The Workshop Leaders

John Shabushnig, Insight Pharma Consulting
Romain Veillon, GSK

SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • John Shabushnig, Insight Pharma Consulting
  • Romain Veillon, GSK
  • Markus Lankers, MIBIC
  • Swen Maas, M.A.S
  • Falk Klar, PDA Europe
  • Caroline Lynar, Manager Programs & Events, PDA Europe
 

Standard Pricing

Standard Member Price

€530

GovernmentMember Only

€530

Health AuthorityMember Only

€530

Early Career ProfessionalMember Only

€530

StudentMember Only

€530

AcademicMember Only

€530

Non-Member

€530

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Tuesday, 14 November

09:30 | Welcome and Introduction
Falk Klar, PDA Europe; John Shabushnig, Insight Pharma Consulting; Romain Veillon, GSK

  • Benefits of the PDA Interest Group
  • PDA Connect

09:35 | EU GMP Annex 1 and U.S. FDA Particle Guidance Perspective
John Shabushnig, Insight Pharma Consulting

09:45 | Group Discussion

  • Annex 1: Defect kit design and frequency of use for daily AVI performance tests
  • Annex 1: Implementation experience and practical considerations
  • U.S. FDA Guidance: Reaction to new expectations

10:30 - 11:00
Coffee Break

11:00 | Continued Group Discussions

12:00 - 13:00
Lunch Break

13:00 | Practical Consideration of Test Sets
Matthias Eisele M.A.S

13:10 | Open Group Discussion

  • Risk analysis on defects
  • Building test kits based on the risk analysis

13:55 | How Do You Characterize Particles?
Markus Lankers, MIBIC

14:05 | Open Group Discussion

  • What level of particle characterization
  • New particle guidance on clinical batch
  • How to differentiate extrinsic and intrinsic

14:50 - 15:20
Coffee Break

15:20 | Recap from the 2023 PDA Visual Inspection Forum
John Shabushnig, Insight Pharma Consulting; Romain Veillon GSK

15:30 | Open Group Discussion

16:30 | Summary of the Workshop and Take-Home Messages
John Shabushnig, Insight Pharma Consulting; Romain Veillon GSK

17:00 | End of Workshop and Farewell

Agenda is subject to change without notice, Speakers are invited, pending confirmation

Agenda is subject to change.

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.

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.

How to Get Here
By Air BER Airport is 8,7 km away from the hotel