STERIS WORKSHOP - Annex 1 Cleaning and Disinfection Requirement

• This webinar will discuss how to design a robust cleaning and disinfection program.
• An analysis of the impact of the recent changes to the EU draft Annex 1 on cleaning and disinfection programs will be presented.
• The goal of this webinar is to present practices around cleaning and disinfection procedures to prevent microbial contamination in the cleanrooms and APA (Aseptic Processing Area).
• We will also share the practices gathered from STERIS global online polls.
• Finally, a case study on the cleaning and disinfection for cleanroom startup (Aseptic Processing Area) will be presented.
Led by:
Walid EI Azab
Senior Technical Service Manager, STERIS Corporation
Walid is an Industrial pharmacist, a Qualified Person and Lean Six Sigma green belt. He currently provides technical support related to contamination control program and process validation. He also leads workshops to improve inspection readiness and contamination control levels.
He is an active member of the PDA, ISPE, ECA, and A3P with numerous published articles and book chapters on contamination control. Walid is a member of the A3P GIC working group on sterilization, draft Annex 1, rouging, contamination control strategy and the ECA task force regarding the revision of the EU GMP Annex 1. He also leads workshop at the UPIP-VAPI EU GMP Annex 1 and at the ECA contamination control strategy task force.
Richard Chai
Technical Service Manager, STERIS Corporation
Based in Singapore, Richard has been providing technical support and training to customers related to bioburden control for cleanrooms, as well as cleaning and cleaning validation for product contact surfaces. He is also a frequent industry speaker at industry events such as ISPE and PDA, and co-author of PDA book chapter.
Richard has been with STERIS for 5 years. Prior to joining STERIS, he has 16 years of manufacturing, validation and consultancy experience working in dry powder inhaler plant, biotech sterile fill and finish plant, medical device and biopharmaceutical facilities.