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The presentation explains step by step the most important updates to Annex 1 and the reasons for the changes. As a subject matter expert in aseptic systems and compliance, the speaker has nearly four decades of experience in the pharmaceutical industry at the forefront of operations and quality. This is accompanied by extensive design and refurbishment activities to ensure companies comply with legal expectations. The presentation walks through the key critical changes to Annex 1 across six key themes (Operations, Premises, Equipment and Supplies, People, Quality Control and Qualification and Validation). The impact on the facility and the lessons learned will be shared. The importance of the Contamination Control Strategy in Annex 1 is discussed and how simplified methodology and lessons learned from the production of these texts can be integrated into a world-class industry benchmark. The importance of a robust gap assessment tool is highlighted and the importance of this tool as a precursor to all significant remediation work is captured. Converting the gaps into a robust grievance resolution using battle-tested industry experts is discussed.

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