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« Tuesday July 20, 2010 »
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Best Practices on Six Sigma and CAPA Convergence Start: 07/20/2010 8:00 am End: 07/20/2010 9:00 am This CAPA training will helps in methodologies of Six Sigma and CAPA converging and how to recognize which methodology is best to use for a problem. Why Should You Attend: Simply documenting "it broke - I fixed it" does very little to instill permanent solutions. Six Sigma methodologies is an ideal toolbox for drilling into the root causes of problems and making certain that permanent solutions are in place. The true spirit of CAPA and Six Sigma is the improvement for the overall system and the reduction in variation around a previously established "centered" process. Too many companies focus on the speed with which CAPAs are closed, yet pay too little attention to the effectiveness and longevity of the solution. Competing Six Sigma and CAPA processes are creating duplication and drawing from same resources. Projects have to be documented in two ways – one for CAPA and another for Six Sigma. Attend this Webinar to Lean how to integrate both so the organization gets the best of both worlds – CAPA and Six Sigma. Areas Covered in the Seminar: Why are the methodologies of Six Sigma and CAPA converging? Why do companies have duplicate and competing Six Sigma and CAPA programs. How to recognize which methodology is best to use for a problem. How should my quality systems work together? Best Practices. Should Electronic Signatures apply to my Enterprise Six Sigma system? Note: Use this Promo Code(100759) to avail Discount of 10% on LIVE Purchase. FDA's New Enforcement of 21 CFR Part 11 Start: 07/20/2010 9:00 am End: 07/20/2010 10:15 am Learn FDA requirements for 21 CFR Part 11, understand how to implement with the help of SOPs and case studies. Why Should You Attend: Though FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just in 2007/2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. Also FDA's computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies. This seminar will give a good understanding of current and future FDA requirements for 21 CFR Part 11 and provide steps, examples and tools for cost-effective implementation. Attendees will receive SOP to define and document scope and control of part 11. Along with it 15 case studies containing step by step description and recommendation for part 11 requirements. Areas Covered in the Seminar : FDA's current inspection and enforcement practices. FDA's current interpretation: learning from FDA guidance, and FDA conference presentations and discussions. Learning from FDA inspection reports. Part 11 and the new EU Annex 11: similarity and differences. Strategy for cost-effective implementation of the 'new' Part 11:A six step plan. Recommended changes to existing Part 11 programs to reduce costs. Justification and documentation for the FDA and your management. Going through case studies from laboratories, offices and manufacturing. Preparing for Part 11 Inspections. The Science of Maximizing Order To Cash Process Performance through Genpact’s OTC SEP (Smart Enterprise Process) Start: 07/20/2010 11:00 am How Can Your Organization Build a Scientific Roadmap to World Class Performance on the Key Business Outcomes? Organizations lack science in managing, measuring and improving business processes. Attend this webinar to gain insight from Genpact’s OTC Practice Leader Mark Wood into how to achieve an end-to-end process view, and focus on improving effectiveness metrics rather than efficiency metrics. Learn how to measure some critical business outcomes, such as Revenue Dilution, as the opportunity gain is 5 to 10 times the impact achieved through reducing costs. Join this webinar to find out how Genpact’s Order To Cash SEP can help you maximize business impact for your company. Key learnings from this session include: A granular approach to process management and measurement Critical business outcomes for the Order to Cash process including a deep dive into Revenue Dilution Top performance measures and drivers and the linkages to business outcomes Key process and technology Insights that significantly impact your business outcomes The MDM Business Case, Opportunities and Pitfalls Start: 07/20/2010 11:00 am End: 07/20/2010 11:00 am Master Data Management provides a consistent and reliable source of truth for any critical data assets such as suppliers, locations, employees, customers, contracts, projects and even cross system reference data. Gaining alignment of your important data, helps you gain alignment across your organization and ultimately save dollars along the way. During this webinar on MDM/governance opportunities and pitfalls, you will learn: •How to build a business case for MDM and governance •The top THREE reasons for failed MDM business cases and how to avoid them •How to find opportunities to start small with MDM •The FIVE steps to a successful master data management project •Essential resources and the tools you need for success Download Talend MDM Community Edition today: http://www.talend.com/download_form.php?cont=mdm Consulting and implementation partner Decision Technologies: www.DecisionTechnologies.com Register Today : http://nxy.in/zw2ml Tue, Jul 20, 2010 11:00 AM - 12:00 PM PDT