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ECA Visual Inspection of Parenterals 2023
ECA Visual Inspection of Parenterals 2023
ECA Visual Inspection of Parenterals 2023
Speakers
Visual Inspection
of Parenterals
Martin Dearden
ECA Visual Inspection
Group
Felix Krumbein
Head ECA Visual
Inspection Group
Christof Langer
OSConsulting
Dr Stephen Langille
formerly FDA
Dr Daniel Müller
Image: Seidenader
GMP-Inspector
Highlights
FDA’s new Guidance on Visual Inspection
Compliance with EU Annex 1 and the Pharmacopeias
Requirements from a GMP Inspector’s View
Test Sets: Preparation, Handling and Usage
Particles: Sources, Risks and Evaluation
Manual Inspection
- Conception
- Training & Qualification
- Workplace
Fully-Automated Inspection
- Setup of the System
- Qualification & Validation
- Minimisation of false Rejects
- Issues during Routine Inspection
AQL Testing & Monitoring of Inspection Data
Visual Inspection in the Production of Clinical Trials
Transfer of a Visual Inspection Process
Dr Stephen Langille
ValSource, formerly FDA
Dr Daniel Müller
GMP Inspector, Germany
____________________________________
Title, first name, surname
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Date of the Conference Organisation and Contact
Tuesday, 26 September 2023, 09.00 to approx. 17.45 h ECA has entrusted Concept Heidelberg with the
(Registration and coffee 08.30 – 09.00 h) organisation of this event.
Wednesday, 27 September 2023, 08.30 to approx. 15.00 h
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