Mundane Monsters of Stability Compliance – Inventory

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Sometimes it’s the everyday things that have been in place forever that are our undoing.  Because they are not related to a hot project with a regulatory filing deadline and would “take forever” to fix with resources not currently available, they continually sink to the lower end of a priority list.  We do temporary fixes, work-arounds, or even look the other way when additional complexities further undermine our systems.  That is, until a 483 or worse, jolts us into action.  This webinar will help us recognize weaknesses in our inventory systems and provide pathways to improvement so we can jog, rather than jolt our way toward contemporary compliance.


Top Ten Benefits to Attending:
  • Recognize Risk Factors in the Stability Inventory Process
  • Find Pitfalls in System Access and Training Levels
  • Determine the True Cost For an Inventory Error
  • Tips to Prevent Stability Sample Mix-Ups
  • Technology For Taking Your System Up a Notch
  • Inventory Impacts to Data Integrity
  • What Allies You Need to Secure Your Systems.
  • What Trojan Horses Wheel Up to Your Gates
  • Extending Vigilance to External Channels (Partners/CROs/Other Corporate Sites)
  • Prepare Sample Inventory Elements in Your Area For Inspection
      • Prepare Sample Inventory elements in your area for inspection

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John O'Neill

Stability Information Specialist, Nagano Science

John has a degree in Pharmaceutical Sciences from Columbia University and a Masters in Health Systems Management from Union University. His experience includes: Registered Pharmacist, Liquids and Semi-solids Formulator at Sterling Winthrop, QC Manager at Sanofi-Aventis, Medical Device Quality Steward at Boston Scientific, Independent Consultant, Principal Stability Specialist for Biologics at Genentech, and Associate Director for Stability at both Gilead and Regeneron. For the past 30 years, John has been the Facilitator of the Pharmaceutical Stability Discussion Group, which has made him privy to just about everything that can go right or wrong with the Stability process. As president of John ONeill Enterprises LLC, he currently serves as Stability Information Specialist for Nagano Science LTD. and has launched Stability Hub, a website to provide stability information of all types for those connected with the Stability function.