2022 PDA Visual Inspection Workshop

Berlin, Germany
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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.

 

Standard Pricing

Standard Member Price

€450

GovernmentMember Only

€450

Health AuthorityMember Only

€450

Early Career ProfessionalMember Only

€450

StudentMember Only

€450

AcademicMember Only

€450

Non-Member

€450

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, 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

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.

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.


*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
How to Get Here
By Air BER Airport: 12.43 kilometers
By Car Self parking: EUR 38.00 incl. VAT