Joe Day

Senior Consultant, GxPAssure

Joe has extensive and diverse high-level experience and proven accomplishments within Sterility Assurance & Aseptic Processing, Quality, Manufacturing, Validation, Regulatory Affairs, SCM and CRM and is a Subject Matter Expert in numerous areas.

Joe is a world expert in all aspects of Sterility Assurance and Aseptic Processing, including Contamination Control, Environmental Monitoring (inc. EM Trending), Aseptic Process Design, Aseptic Process Simulations, Critical Utilities, Cleaning & Disinfection, Aseptic Techniques, Set-up & Processes, Operator Behaviour & Training and Personnel, Equipment & Material Flows.

Joe has supported multiple companies in remediating observations related to Warning Letters, 483s, HPFBI, EMA and Global Regulatory inspections.

Joe has expertise establishing, assessing, developing, maintaining and improving Quality Systems to ensure Best Practices, Regulatory Compliance and the optimization of Operational Efficiency, (Start-Up to Multi-National).

Joe is adept at supporting companies in Inspection Management, (FDA, HPFBI, EMEA, Notified Bodies, WHO and numerous other Regulatory bodies).