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Pharm Cafe Nick Haycocks TUESDAY 5 Nov 13.30‐15.00 Content Level 301: Pharma Café Time 13.30‐13.35 Presentation Title Welcome and Introductions ‐ Nick Speaker Intros ‐ John & Randy 13.35‐13.50 Session Leaders: Nick Haycocks, Senior QA Specialist, Amgen Inc., USA John Musaus, Global Director, MWV Healthcare, USA Randolph Leinhauser, Associate Director, Engineering, Merck, USA Intermediate Non‐Destructive Package Inspection Technologies Speakers Name Nick Haycocks John Musaus Randolph Leinhauser Oliver Stauffer Company Email Amgen Inc., USA MWV Healthcare, USA Merck, USA PTI ‐ Packaging Technologies & Inspection, USA Carmine Stropoli Middough Inc., USA Bikash Chatterjee Pharmatech Associates, USA Randy Turner Swan Analytical USA Gain insight into defining the Critical to Quality (CTQ) leak size for various package and container formats and how to fully understand the package barrier, in particular methods for inspecting the sterile barrier and how they can be challenged. 13.50‐14.05 Electronic Sensor Technology for Inline Measurement An electronic sensor system has been developed for non‐contact measuring the mass of product being filled into containers (vials, cartridges, syringes, etc.), on a filling machine. 14.05‐14.20 Securing Information Across The Global Supply Chain This presentation will discuss state‐of‐the‐art technologies which are being used to ensure the integrity of drug substance, drug product and components today. The presentation will culminate in a short demonstration of a cloaking technology that is being used to hide networks and local LAN’s from hackers. 14.20‐14.35 TOC Innovations for Direct UV ‐ Oxidation in Pharma TOC must be measured in Pharma therefore the industry needs a simple, reliable analyzer that requires little maintenance, & easily performs SST's. This report gives a brief outline of the general measuring methods. It illustrates the possibilities and limitations of the direct UV‐Oxidation, and technical modifications made to the monitoring instrument, AMI Line‐TOC, to improve the performance of the UV‐reactor improving instrument precision. 14.35‐15.00 Technology Round Table Discussions All Speakers ‐ One per Group SESSION ADJOURNS AT 15.00 to EXHIBIT HALL Description The competitive environment of the pharmaceutical industry demands that companies continuously update manufacturing processes to improve quality, efficiency and cost containment. Cutting‐edge technologies offer timely and cost‐effective solutions to industry challenges. Selected exhibitors offer an in‐depth look at the science behind their products. Hear brief presentations on cutting edge technologies from a non‐commercial perspective followed by roundtable discussions focused on each technology presented. Presenters will offer insights into the effectiveness and implications of each technology. Objectives • Gain basic knowledge of innovative technologies • Understand the effectiveness and implications of each technology • Assess the applicability of each technology to current operations