8 Sep 2022
5.00-6.30pm SGT | Online
Hosted by:
Abstract:
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. Then, 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.
Speaker:
Walid EI Azab, Senior Technical Service Manager, STERIS Corporation
Walid El Azab is an Industrial pharmacist and a Qualified Person (QP). He is a Senior Manager of Technical Services for the Life Sciences Division of STERIS Corporation.
He currently provides technical support related to cleaning, disinfectants, sterility assurance, and process validation.
He also leads workshops to improve inspection readiness and contamination control levels.
His areas of expertise include both upstream and downstream pharmaceutical operation and validation in non-sterile and sterile process.
Walid has held various positions including Project Manager, Inspection Readiness Manager, Quality and Regulatory Manager, lead auditor, and QP. Walid’s responsibilities and experience have also included project management, handling deviations and complaints, releasing raw materials, drug products and investigational medicinal product (IMP), conducting external audits of suppliers, and leading customer and regulatory (FDA, EMA, SFDA, ANVISA…) audits and develop strategy approach for process, cleaning, and system gap analysis
Walid earned a Master’s degree in Industrial Pharmaceutical Sciences from the University of Liège, Belgium and is a certified Lean Six Sigma green belt. Walid is a lecturer at the University of Liège (Medicine faculty in Belgium).
He is an active member of the PDA, ISPE, ECA, and A3P associations with numerous published articles and book chapters on contamination control. He is also active with the A3P GIC working groups on sterilization and derouging and passivation, and he leads the UPIP-VAPI EU GMP Annex 1 (guidance for sterile manufacturing) working group, and he is also part of the ECA task force regarding the revision of the EU GMP Annex 1.
Also, he will be leading the future ECA task force on contamination control strategy.
He was a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology and he is a planning committee member of the European Biomanufacturing (1st and 2nd). He is also an Editorial and the sub art committee member of the PDA Letter. Finally, Walid is a board member of the Belgium Qualified Person (UPIP-VAPI) association and co-founder of the Belgium QP academy.