Tuesday, 29 October
*Agenda is subject to change*
08:00 - 17:00
Registration Open
08:00 - 09:00
Continental Breakfast
09:00 - 09:05
Opening Remarks
Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA
09:05 - 14:10
P1: Inspection Trends Based on Region
This session will give an overview on regulatory and compendial developments and trends on the topics of visual inspection and container integrity globally with a focus on the regions Japan/Asia-Pacific, Europe and the USA. Industry experts will share their positions on these developments.
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA
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09:05 - 09:30
Regulator's View on Up-Grading Guidance for Visual Inspection and Container Integrity
Tetsuhito Takarada, Expert, Pharmaceutical and Medical Device Agency
09:30 - 09:55
New General Information on Package Integrity Evaluation of Sterile Pharmaceutical Products in Japanese Pharmacopeia
Ken-ichi Izutsu, PhD, Chair of JP WG, Head of Test Method Group, National Institute of Health Sciences (NIHS)
09:55 - 10:25
ICH Q2, Q14; Its Influence to Container Integrity and Visual Inspection
Yukio Hiyama, PhD, Visiting Scientist, National Institute of Health Sciences (NIHS)
10:25 - 11:00
Industry Perspective on Visual Inspection and Container Closure
Hirohito Katayama, PhD, PDA Sterile Product Task Force (Japan), Bayer Yakuhin Ltd.
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11:00 - 11:30
Coffee Break and Exhibition
11:30 - 14:10
P1: Inspection Trends Based on Region CONTINUED
This session will give an overview on regulatory and compendial developments and trends on the topics of visual inspection and container integrity globally with a focus on the regions Japan/Asia-Pacific, Europe and the USA. Industry experts will share their positions on these developments.
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA
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11:30 - 12:20
Regulatory (FDA) and Compendial (USP) Updates from the USA
John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
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12:20 - 13:20
Networking Lunch
13:20 - 14:10
P1: Inspection Trends Based on Region CONTINUED
This session will give an overview on regulatory and compendial developments and trends on the topics of visual inspection and container integrity globally with a focus on the regions Japan/Asia-Pacific, Europe and the USA. Industry experts will share their positions on these developments.
Moderator: Georg Roessling, PhD, Senior Consultant, Business Development Asia, PDA
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13:20 - 14:10
Visual Inspection & Container Integrity – European Considerations
Hanns-Christian Mahler, Prof., Head of Drug Product Services, Lonza AG
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14:10 - 15:00
P2: Summary of TR79 - Difficult to Inspect Products
This presentation will summarize the PDA Technical Report on "Difficult to Inspect Products". These are products which can be turbid, colored or have challenges which need different approaches for inspection.
Moderator: Hanns-Christian Mahler, PhD, Prof., Head of Drug Product Services, Lonza AG
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14:10 - 14:40
PDA Technical Report 79: Particulate Matter Control in Difficult to Inspect Parenterals
John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
14:40 - 15:00
Questions and Answers/Discussion
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15:00 - 15:30
Coffee Break and Exhibition
15:30 - 18:20
P3: Tech Update on Visual Inspection Technologies
This session will give an overview of new technical developments and best industry practices of visual inspection of injectable products. Equipment, machines, new procedures and concepts of visual inspection will be presented.
Moderator: John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
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15:30 - 16:20
Automatic Visual Inspection of Lyophilized Products, Characterizes as Difficult to Inspect Products (DIP), with Very Low False Reject
Andrea Sardella, PhD, Pharma Inspection Product Development Manager, Stevanato Group Engineering Systems
16:20 - 17:10
Deep Learning for Visual Inspection - Implementation in Automated Inspection Machine Under Production Conditions
Jose Zanardi, Senior Manager, Engineering Vision Technology, Bosch Packaging Technology K. K.
17:10 - 18:00
Spectral-coded Illumination for Reliable Differentiation Between Transparent Particles and Air Bubbles
Stefan Stehling, Sales Manager, Inspection Applications, Seidenader Maschinenbau GmbH
18:00 - 18:20
Questions and Answers/Discussion
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18:20 - 20:30
Networking Reception