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Interest Group Meeting Visual Inspection

Annex 1 Revision on Visual Inspection and on Container Closure Integrity
Apr 13 - Apr 13, 2018 |
Apr 13, 2018 |
Courtyard by Marriott Berlin City Center | Berlin, Germany
  • Interest Group
  • Europe
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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 touches on the important topics of container closure integrity control and visual inspection rather briefly, the revision offers a number of innovations.

The new requirements issued with this amendment provoke further discussion of the correct under­standing and implementation.

We are excited to announce our 2018 Visual Inspection Interest Group Meeting with the main focus on the impact of the Annex 1 Revision on Visual Inspection and on Container Closure Integrity.

The PDA Interest Groups are discussion forums, each with a highly focused topic of interest. The main idea behind this workshop is to engage in questions raised by attendees and to have a more in-depth discussion compared to the usual presentation-driven meetings. You are invited to contribute and provide your questions to the group, and together develop possible solutions to these challenging issues. Industry experts will be participating to help facilitate the discussion.

As a thematic framework, the IG Leaders have chosen the following topics for this exciting workshop:

  • Container Closure Integrity Testing – The Impact of the Annex 1 Revision
    • Choosing the right techniques and meeting new standards
    • Which requirements apply for different containers?
  • Visual Inspection – Understanding and Implementing the Annex 1 Revision
    • Impact of worst case scenarios
    • New implications for semi-automated inspection
    • Accepted Quality Levels

Friday, 13 April 2018

10:00
Welcome and Introduction
Falk Klar, PDA Europe
John Shabushnig, Insight Pharma Consulting
Markus Lankers, rap.ID

  • Benefits of the PDA Interest Group
  • PDA Connect

The Annex 1 Revision in Visual Inspection and Container Closure Integrity

10:15
What's New in Annex 1? Highlights and Comparison to USP
John Shabushnig, Insight Pharma Consulting

Visual Inspection: Understanding and Implementing the Annex 1 Revision

10:45
General Requirements for Visual Inspection


11:30
Coffee Break and Exhibition

12:00
Manual Inspection Automated Inspection


13:00
Lunch Break and Exhibition

14:00
Trending Inspection Results

Container Closure Integrity Testing - Impact of the Annex 1 Revision

14:30
Container Closure Integrity Testing – The Impact of the Annex 1 Revision
Derek Duncan, LIGHTHOUSE


15:00
Coffee Break and Exhibition

15:30
Choosing the Right Techniques – What is Required for Different Containers?


16:00
Summary Remarks
Falk Klar, PDA Europe
John Shabushnig, Insight Pharma Consulting
Markus Lankers, rap.ID


17:00
End of IG Meeting and Farewell

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

300 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.

PDA Europe has reserved a limited number of rooms until the 16th February 2018.

Book your room for the PDA Group Rate

Single Room € 135 per night*
Double Room € 145 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Free Wi-Fi
  • VAT, Taxes and Service Charge will apply

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=4155

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