Join our CCI Testing Workshop
When: Thursday, May 9th, 2019
Where: Lighthouse Instruments European Support Center, Science Park, Amsterdam
Time: 9:30 AM - 5:00 PM (Amsterdam time)
Topics covered will include :
-
The changing regulatory landscape and the use of modern CCI testing techniques: New regulatory requirements, including updates to the EU Annex 1 and USP <1207>, will be covered and an overview of CCI testing methods will be given.
-
Industry case studies: Real world CCI testing cases will be presented, covering CCI testing practices throughout the product life cycle, from Development to Manufacturing and Quality Control.
-
Strategies for statistical sampling in sterile manufacturing: Regulators are paying closer attention to the generation of statistical data. This presentation will provide a framework for developing a statistical sampling strategy.
-
Approaches for CCI test method development and validation: Guidance will be given for the proper design of robust CCI studies, method development and validation of CCI testing methods. Including the use of positive controls and leak rate modeling.
Click here for the full Agenda and Workshop details.
The price for the workshop is EUR 500,- per ticket, excluding VAT. This includes a pre-workshop activity and dinner in Amsterdam on the evening of May 8th. Spaces for the workshop are limited so register today!