25-26 October 2016 | Berlin | Germany
Paper abstracts and posters must be non-commercial in nature, describing new developments or work that significantly contributes to the body of knowledge relating to Visual Inspection.
Case Studies are particularly desired.
Purely commercial abstracts for papers or posters cannot be considered.
All submitted abstracts will be reviewed by the Program Committee for acceptance. Upon review by the
Program Committee, PDA Europe will advise each submitter of the status of the paper for presentation in writing. PDA Europe will provide one complimentary registration per podium presentation. Additional presenters and poster presenters are required to pay appropriate conference registration fees.
Submissions received must include the following information:
- Title
- Presenter
- Presenter’s biography (approx. 100 words)
- Additional authors
- Full mailing address
- Phone number
- Fax number
- E-mail address of the presenter
- Key objectives of your topic
- 2-3 paragraph abstract, summarizing your topic
Please send your abstract and required information to Melanie Decker, decker@pda.org
or use the link below.
If you have any questions, please do not hesitate to contact us.
Attention Exhibitors
PDA is seeking vendors who provide excellent products/services in support of this conference.
Space is limited and is on a first-come, first-serve basis.
To reserve your space, please contact Creixell Espilla-Gilart at espilla@pda.org or via telephone +49 30 4365508-14.
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1. Regulatory Updates:
• Regulatory requirements affecting the visual inspection process
• Implementation of USP <790>
2. Inspection Process:
• Fundamental investigations into inspection processes
• Development and control of manual inspection processes
• New developments in automated inspection technology
• Preparation and use of standards in assessing visual inspection processes
• Definition and classification of defects and the preparation of defect libraries
• Challenges of difficult to inspect products (lyophilized, suspensions, viscous solutions, large molecule, pre-filled syringes, flexible bags, etc.)
• Use of acceptance sampling and AQL´s
3. Particle Identification & Source Analysis
• Particulate/Foreign material identification
• Contribution of packaging components to visible particles
• Foreign material sources in the manufacturing environment and their control
4. Case Studies (possible topics)
• Particulate or defect control and inspection
• Validation of automated inspection systems
• Selection and training of human inspectors
• 2 step inspection process
5. Inspection of Biopharmaceuticals
• Special considerations for the inspection of biopharmaceuticals
• Detection and characterization of protein aggregation
6. Clinical Impact of Particles
• Clinical impact / patient risk of particles
• Risk assessment for products using different injection routes
(i.m., sub-Q, i.v., intraocular, etc.)
• Subvisible particles
Please click here to submit your abstract
Deadlines Abstracts of papers for presentation: 31 May 2016
Poster abstracts: 26 August 2016 pda.org/EU/VisualInspection2016
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