GlobalCompliancePanel, Intercontinental The LaLit, Sahar Airport Road, Andheri East Mumbai - 400059 INDIA
2012-08-06
Overview: This training course has been designed to address the processes, methods, and tools associated with Quality Risk Management. It highlights the disciplined environment that is necessary for proactive decision making to continuously assess what risks a organization is exposed to, which risks are important to deal with and how the implementation of strategies can mitigate risks. Additionally, the course provides trainees with skills to develop, deploy and extend the functionality of a risk management system by effectively analyzing and producing enterprise-wide risk management tools and measures. Specifically, it address the skills needed to acquire data from disparate data sources, develop appropriate risk factor models, perform risk analysis and create results-based reports. Why should you attend: As QRM tools and techniques become more formalized, regulatory agencies are requiring companies to establish Quality Risk Management Plans and using them as starting points for their audits. Additionally, to keep in step with the evolution of science and technology, agencies are frequently updating their approach to quality and risk management and they expect the companies to remain agile enough to modify their QRM plans to reflect changing regulations. This dynamic nature has significantly contributed to increase in citations. Furthermore, while processes may vary, the principles and techniques of QRM for these varied processes are the same. If you ask companies how they define risk, you will get different answers. This disparity in understanding of risk and QRM principles puts them at risk of audit failures. They need to reduce their exposure to risk of being cited by performing QRM using the same language of risk as spoken by the auditors. Seminar Content: India Seminar 2012 at Mumbai Day 1 - 6th August 2012 · Lecture 1: QRM's broader context · Lecture 2: Introduction to QRM · Lecture 3: Systems Approach to QRM · Lecture 4: Risk Assessment Overview · Lecture 5: Risk Identification Day 2 - 7th August 2012 · Lecture 6: Risk Control · Lecture 7: Risk Communication · Lecture 8: Selection & use of QRM Tools · Lecture 9: Integrating QRM into QMS · Lecture 10: How is QRM audited and how to defend a QRM Audit Who Will Benefit • Middle and upper level managers
• Quality Compliance Professionals
• R&D and Technology Transfer Personnel
• Production Managers
• Manufacturing
• Engineering and IT
• R&D Personnel
• Validation Service Providers
• Clinical Development
• Pharmaceutical/Medical Device/Healthcare /Engineering personnel DATE AND VENUE: 6th and 7th August, 2012 at Mumbai Conference Timings: 9:00 am - 6:00 pm Venue: Intercontinental The LaLit Sahar Airport Road, Andheri East
Mumbai - 400059 INDIA Contact Information: Event Coordinator Phone number: +91 80-3247-3694 / +91 80-3201-4957 FAX : +91 80-2642-1483 Email: customersupport@globalcompliancepanel.com GlobalCompliancePanel NetZealous Services India Pvt. Ltd. 4th Floor, A, Block, Brigade Software Park, Banashankari 2nd stage, Bangalore-560070. INDIA.
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