Description of event:
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
• Engineering and IT
• R&D Personnel
• Validation Service Providers
• Clinical Development
• Pharmaceutical/Medical Device/Healthcare /Engineering personnel
Chinmoy Roy is a seasoned Life Sciences professional. His expertise includes the design, delivery and validation of industry compliant computerized and control systems for pharmaceutical and biotech manufacturing. His focus is on finding lean integrated manufacturing solutions to include Quality by Design (QBD) and Quality Risk Management (QRM).
He is an engineering graduate from IIT and has been based in the US. He has more than 35 years of hands on industry experience in directing the implementation, validation and obtaining "fit for use" certification of large biopharmaceutical manufacturing automation and IT systems. These systems conform to regulatory requirements such as CFR 21 Part 11 and Annex 11. He has a very broad experience in facilitating QRM sessions for large US companies and has provided them with consultant oversight to establish their Quality Risk Management plans.
His training sessions are unique in that he combines his field experience to explain the intricacies of applying the regulations. Such an approach of blending theory with practical applications has provided his trainees the necessary skills to lead regulatory efforts in their respective organizations.
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
Price – Rs 22000
Phone number: +91 80-3247-3694 / +91 80-3201-4957
FAX : +91 80-2642-1483
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