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2022 VIForum_1988x680

2022 PDA Visual Inspection Workshop

Nov 08, 2022
Berlin, Germany

Common Issues for Visual Inspection and Container Closure Integrity

  • Workshop
  • Europe

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Overview

This one-day meeting on visual inspection (VI) will be held in Berlin on 8 November. One of the PDA Interest Group Leader John Shabushnig and Derek Duncan will provide updates on critical inspection topics followed by a group discussion. Topics include recent regulatory activity, challenges encountered during visual inspection qualification and validation of VI processes, inspection of difficult to inspect products (DIP), and advances in container closure integrity testing (CCIT) and leak detection. We have identified a limited number of topics for discussion to allow a thorough review and development of practical solutions which can be applied to your inspection program. At the end of the day, we will have a panel discussion to address additional topics that are of interest to attendees.

Agenda

  • Tuesday, 8 November

    09:30 | Welcome and Introduction
    Falk Klar, PDA Europe; John Shabushnig, Insight Pharma Consulting; Derek Duncan, LIGHTHOUSE Instruments

    • Benefits of the PDA Interest Group
    • PDA Content

    Combined Visual Inspection and Container Closure Integrity Discussion

    09:35 | Stimuli presentation: Recent Regulatory and Compendial Publications Driving Change for Visual Inspection (VI) and Container/Closure Integrity (CCI) Testing
    John Shabushnig, Insight Pharma Consulting

    09:45 | Group Discussion
    Moderators: John Shabushnig, Insight Pharma Consulting; Derek Duncan, LIGHTHOUSE Instruments

    • Annex 1
    • FDA Guidance
    • Sampling plans for Container Closure Integrity and Visual Inspection

    10:30 - 11:00
    Coffee Break

    11:00 | Continued Group Discussions:
    Moderators: John Shabushnig, Insight Pharma Consulting; Derek Duncan, LIGHTHOUSE Instruments

    • Combined CCI and Visual Inspection Platforms

    12:00 - 13:00
    Lunch Break

    Visual Inspection Discussion

    13:00
    John Shabushnig, Insight Pharma Consulting

    • Visual Inspection of ATMPs
    • Inspection Qualification and Validation
    • Defect sets for Visual Inspection

    13:10 | Open Group Discussion
    John Shabushnig, Insight Pharma Consulting; Derek Duncan, LIGHTHOUSE Instruments

    14:30 - 15:00
    Coffee Break

    Container Closure Integrity Discussion

    15:00
    Derek Duncan, LIGHTHOUSE Instruments

    • DIP and flexible Bags
    • Leak Detection and Calibration
    • Defect sets for CCIT

    15:10 | Open Group Discussion
    Derek Duncan, LIGHTHOUSE Instruments, John Shabushnig, Insight Pharma Consulting

    16:30 | Summary of the Workshop and Take-Home Messages

    John Shabushnig, Insight Pharma Consulting;  

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

Additional Information

  • Learning Objectives

    Learning Objectives

     
  • Who Should Attend

    Departments

    Engineering | Manufacturing | Packaging | Process Development | Quality | Technical Services | Validation

    Pharmaceutical/Biopharmaceutical Developers

    Clinical Supplies | Parenteral Development | Process Development

    Inspection Equipment Suppliers

    Applications Development | Machine Design | Sales

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Travel

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.

Hilton Berlin

Mohrenstrasse 30
Berlin, Germany

Make a Reservation

Single Room € 189 per night*
Double Room € 209 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 Standard)
  • VAT, Taxes and Service will apply

Make your reservations as early as possible to guarantee your room. PDA Europe has reserved a limited number of rooms until 12 September 2022.

Rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

  • Accommodations

    *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 Standard)
    • VAT, Taxes and Service will apply
  • Amenities

How to Get Here

By Air

BER Airport: 12.43 kilometers

By Car

Self parking: EUR 38.00 incl. VAT

Other Options

Located on historic Gendarmenmarkt, the Hilton Berlin hotel has easy access to public transportation (station: Stadtmitte, metro lines U6/U2).

Directions

Registration Fees

Regular Price
Registration Type Fee
All Participants €450

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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