Validation review Expert QA review of validation protocols, final reports and master plans. Experienced in the following: Equipment & Processes Aseptic Processing Filling & Packaging Buffer & Media Vessels Cell Culture & Purification Liquid Fills Lyophilization Bioreactors Purification Equipment Autoclaves Depyrogenation Ovens Vial Washers Glasswashers Steam-in-Place (SIP) Clean-in-Place (CIP) Critical Utilities WFI & Purified Water System HVAC Systems Clean Steam Nitrogen Compressed Air Temperature Control Units Incubators Refrigerators/Freezers Cold Rooms Warm Rooms Warehouses Apply the concepts of "Statistical Thinking" to your data and everyday work environment. Address some of the issues, and avoid the problems and pitfalls, concerning the collection and use of data. Understanding the fundamentals of variation. Use visual data analysis for discovery and understanding. Table and Graph Design for Effective Communication Effectively communicate quantitative business data using tables and graphs. Show how to select the appropriate medium of communication (table vs. graph, and which type) and how to visually design each component to express your message clearly and compellingly. Show how to make the best use of the charting and graphing functions in Microsoft Excel. Development of quality system metrics Can assist in the development of quality system metrics and measures to monitor the effectiveness of the quality system and, when appropriate, to implement corrective and preventive action. Effective use will drive the organization to higher levels of performance. Problem solving, root cause analysis, continuous improvement CAPA and deviation investigations Product Complaints Handling Investigation Management Batch record review Change control Supplier quality management |