Presentation will go through step by step the key updates to Annex 1 and the reasons behind the changes. As a subject matter expert in Aseptic facilities and compliance, the presenter has almost four decades of experience within the Pharmaceutical Industry at the sharp end of Operations and Quality. This is coupled with extensive design and remediation activities to ensure companies get compliant to regulatory expectations. The presentation will guide through the key critical changes to the Annex 1 into six main topics (Operations, Premises, Equipment and utilities, People, Quality Control and Qualification & Validation). The impact on the facility and the learnings from these will be shared. The importance of the Contamination Control Strategy within Annex 1 will be discussed and how simplified methodology and wisdom from writing these can be incorporated into a world class Industry benchmark. The importance of a robust Gap Assessment tool will be highlighted and the importance of this as a precursor to any significant remediation work will be captured. The conversion of the Gaps to a robust complaint fix, using battle hardened Industry experts will be discussed.