September 28, 2022
Annex 1, CCS, Contamination Control Strategy, ECA, eipg, ICH, task force on the revision of Annex 1, template, Walid El Azab, webinar
The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 21st of October 2022 (16.00 CEST), on the implementation of Contamination Control Strategy (CCS) using the ECA* template. This is the second presentation on the CCS, given by Walid El Azab, Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation, an Industrial Pharmacist and a Qualified Person (QP), member of the ECA task force on the revision of Annex 1 and leading expert on the subject.
Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality. Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulate contamination.
The presentation explains the implementation of a CCS across a facility and deep dive into the ECA guideline on CCS. An example of CCS implemented by various manufacturers and the ECA CCS template will be presented. This will be followed by a discussion around the future challenges manufacturers may face with the principle of a holistic approach and how novel technology and data science combined with statistics may help in overcoming the future challenges.
This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.
- European Compliance Academy