The presentation will highlight the different regulatory requirements regarding steam sterilization management, validation, and requalification against the draft Annex 1. An update of the draft Annex 1 status will be shared. This presentation will analyze the requirements for steam used for sterilization and approaches to steam sterilization of product, equipment, and packaging components. Comments on the proposed requirements related to steam quality and moist steam sterilization will be shared. The presentation will suggest parameters to analyze and consider when developing risk-based justifications. Case studies of common failure observed will be shared with the group.


Walid El Azab

Walid El Azab

Technical Services Manager, STERIS Life Sciences

Walid El Azab is an Industrial pharmacist, a Qualified Person and Lean Six Sigma green belt. He provides technical support related to cleaning, disinfectants, sterility assurance and process validation. He is an active member of the PDA, ISPE, ECA, and A3P with numerous published articles and book chapters on contamination control. He is active with the A3P GIC working group on sterilization, leads the UPIP-VAPI EU GMP Annex 1 (guidance for sterile manufacturing) working group, and is part of the ECA task force regarding the revision of the EU GMP Annex 1. He is a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology and biomanufacturing. He is an Editorial Committee Member of the PDA Letter. Finally, Walid is a board member of the ISPE Belgium affiliate and Secretary of the Belgium Qualified Person (UPIP-VAPI) association.

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