How is the FDA Progressing with its Risk-based Approach to Compliance?
The video blog features QUMAS Compliance Advisor, Warren Perry, who has worked with a number of multi-national Life Sciences firms on regulatory compliance, submission lifecycle management and e-submissions initiatives. This video blog examines how well the U.S. Food and Drug Administration (FDA) is implementing a risk-based approach to compliance in the pharmaceutical, biotech, and devices industries. Troubling red flags in recent months in other sectors raise serious concerns, particularly as all industries become globalized thereby increasing the need for harmonization of pharmaceutical quality standards and requirements internationally. The FDA has been challenged to increase its collaboration with international health and regulatory partners. Now, five years after announcing this approach, it's time to ask: how is the FDA progressing with this initiative? Play >>
Enterprise Risk Management and the Value of Risk
Caoimhe Lynch, Director of Strategy for QUMAS, discusses a wide range of compliance topics with Dan Keldsen from perotsystems Innovation Lab (formerly Delphi Group). In this interview, Caoimhe details the benefits that firms can derive by taking a "closed-loop" approach when dealing with legislative and regulatory compliance requirements. Click here.
Kevin O’Leary, Chief Strategy Officer for QUMAS, argues that IT needs to take a consistent compliance approach throughout the organization. We explore the benefits of a holistic approach to compliance, how to get started, and the benefits to be had. Approaching compliance projects in an organized, holistic fashion can save IT time and frustration. Click here.
About Enterprise System
Enterprise Systems (www.esj.com) is a leading provider of real-world business and technology information for managers of large, high-volume-transaction, high-availability, high-performance computer systems and infrastructures. Enterprise Systems delivers news, analysis, and perspective of immediate use to IT professional staff and management in their daily work life. Enterprise Systems explains, challenges, and enlightens its audience by discussing current issues and developments in IT technologies, case studies, interviews, trends, and forecasts.
Warren Perry, Compliance Advisor for QUMAS, participated in an exclusive interview with Ron Powell and the Business Intelligence Network. In this interview Warren explains how compliance management consolidates and standardizes enterprise compliance and governance components into a comprehensive framework that eliminates the cost of managing isolated applications. To listen to the interview please click here.
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