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ComplianceOnline, Renaissance New York Times Square Hotel, 714 7th Avenue, NewYork
2013-04-04
This training on computer system validation models will explain the distinctions and similarities between three CSV models - V-model, GAMP 5 and ASTM E2500 - and show how you can apply the most appropriate model for your application and significantly reduce your regulatory risk.
Why Should You Attend:
Computer Systems Validation (CSV) has significantly evolved over the past few years. It is no longer an exercise which involves “10 easy steps to CSV”. CSV’s complexity has evolved due to the regulations of the past few years. Consequently, approaches using the classical V model to devise a ten step approach to validation no longer holds true. This is corroborated by the introduction of validation models such as GAMP 5, ASTM 2500 etc. It is critical to obtain an understanding of the distinctions between these models and choosing one that is appropriate for your application. Failure to do so will increase your exposure to audit failure.
This Intermediate to Advanced level webinar from a CSV implementation expert will expand your CSV knowledge and familiarize you with the following:
- An enhanced collapsed CSV architecture to save you time and money and reduce regulatory risk.
- Use of The Capability Maturity model to decrease CSV costs
- How not to fall a victim of “Tag along audits” by the FDA
- Why is Quality Risk Management critical for a successful audit of your CSV efforts
- How is QRM audited
At the conclusion of this webinar, you will be able to determine whether your company’s CSV strategy is vulnerable to the most common violations and what you need to do plug these vulnerabilities.
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Organized by:
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Complianceonline |
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Invited Speakers:
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Chinmoy Roy, is an independent consultant. His specialties include CSV, CFR 21 Part 11, QRM, Internal and External audits, and QA of computer systems in large scale manufacturing, clinical trials and laboratories. His team pioneered the successful implementation of a CFR 21 Part 11 compliant system. This paperless bulk manufacturing control system integrates SAP, MES, LIMS, Weigh and Dispense and DCS. This highly complex system was a precursor to FDA’s Part 11 Scope and Application Guidance document in 2003. He also has a broad experience in facilitating QRM sessions and establishing Quality Risk Management plans for his clients.
Considered an implementation expert, his experience of 37 years along with his engineering and computer science background has provided him with a wealth of experience and insights into the intricacies of applying the regulations. He has been invited by several worldwide professional organizations to share his experience. He presented papers and conducted workshops on state of the art topics such as the fundamental principles and evolving nature of computer systems validation, untying the knot of quality risk management etc. He continues to consult with companies and his list of clients includes several multinationals in the Life Sciences industry.
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Deadline for Abstracts:
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2013-04-03
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Registration:
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http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702795?channel=Hummolgen
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E-mail:
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referral@complianceonline.com
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