Pundit Warren Perry Comments on FDA's Risk-Based Approach to Manufacturing Plant Inspections and Product Quality Review Processes
JERSEY CITY, NJ--(Marketwire - March 18, 2008) - QUMAS, the leader in Enterprise Governance, Risk and Compliance (GRC) solutions, today announced that it has launched a new video blog series around compliance issues. The video blogs feature 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. Perry has been instrumental to highly regulated clients for establishing successful best practices to ensure their firms can achieve and maintain a consistent state of compliance. An authority on compliance issues, Perry has been published in a number of leading Life Sciences publications including Applied Clinical Trials, Bio-IT World, Pharmaceutical Technologist, RAJ Pharma and BioPharm International.
The first video blog in the series 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.
Initiated in 2002, the FDA adopted a risk-based approach that incorporates rigorous analysis to consistently identify the most important risks and to find ways of mitigating risk while facilitating continuous improvement and innovation in pharmaceutical quality in the manufacturing process of veterinary and human drugs and select human biological products such as vaccines.
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?
The video blog can be viewed on the QUMAS web site at: http://www.qumas.com/files/Vblogdraftv1wsp.wvx
QUMAS is the leader in Enterprise Governance, Risk and Compliance (GRC) with more than 250 customer deployments and over a decade of experience helping companies in highly regulated industries provide a proactive regulatory defense.
QUMAS solutions for life sciences are designed to achieve compliance with industry and government standards for 21 CFR Part 11, cGxP, Quality, R&D, Regulatory Affairs and Clinical Operations. QUMAS enables organizations to bring new drugs to market faster with better quality submissions while proactively managing regulated content and controls, reducing costs, and improving customer satisfaction.
For more information visit http://www.qumas.com.
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