Thursday, April 16, 2009

Speakers
Arik Gorban, AVP, Compliance & Quality Strategies, Patni Life Sciences Inc

Webinar Highlights
A harmonized and consistent risk-based computer system validation is an effective way to optimize the investment allocated to corporate compliance programs.
In this webinar, Arik Gorban, Patni’s expert on compliance and quality strategies will share with you how Lean Compliance concepts can reduce your computer-related compliance costs while increasing your level of regulatory compliance.

Regulatory agencies and industry groups promote the adoption of a risk-based approach to computer system validation and compliance with 21 CFR Part 11.  However conservative interpretations of the FDA intentions with regard to risk based compliance are already turning this allowance to an additional burden.

Lean Compliance Models incorporate industry’s best practices with a risk-based approach.  An effective approach may help Life Science companies meet FDA and other regulatory requirements while reducing their computer-related compliance costs by at least 35 percent.  Lean Compliance improves long term supportability of CSV and reduces long term resource requirements.  It promotes:

• A managed approach to computer-related compliance
• Consistent documentation
• Focused resources
• Effective execution
• Coaching for success rather than auditing for failure
• Focus on prevention, not remediation

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