Live Webinar
on
Key Steps for Risk Assessment
Date & Time: Tuesday, January 10, 2012
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: Chinmoy Roy
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview: Chinmoy Roy Biopharma Consultant
The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying
Chinmoy 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).
the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as those of the regulators and thereby significantly reduces your companies exposure to audit failures.
Areas Covered in the Session: l l l l l l l l l l l l l l
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Characteristics, history & FDA’s involvement with QRM In perspective: QbD, QRM and Quality systems ICH Q9 Process Principles of QRM Key elements of QRM Characteristics of QRM Systemic processes and General Failure Types 7 Key concepts in FDA systems approach thinking Swiss cheese model for systemic related safety QRM documentation and their contents Factors for a successful Risk Management process Hazard, Harm, Risk concept Key steps in risk identification Use of scoring criteria and Heat Maps in analyzing and evaluating risks Risk reduction and Risk acceptance basics Factors that establish a Risk Acceptability criteria QRM tools used; their strengths and limitations Selection of appropriate tools for different circumstances
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. ...more
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Click here to register for this webinar Who Will Benefit: l
Project Managers, Lead Engineers, Software Engineers
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Risk Managers and others Performing Risk Management Activities
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Those involved in process improvement Contractor, Consultants Providing Engineering and Validation Services
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QA, Regulatory Affairs, Engineering & IT personnel
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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