Proposed EU Regulatory Changes in Medical Device Directives and What it Means for the Companies in the Device Industry-Krishna Ghosh, Ph.D.-03/31/2009 - 8:30am

Event Information
Event Topic: 
Proposed EU Regulatory Changes in Medical Device Directives and What it Means for the Companies in the Device Industry
Event Date: 
03/31/2009 - 8:30am
Event Location: 
Sunnyvale
Speaker Information
Event Speaker: 
Krishna Ghosh, Ph.D.
Event Speaker Title: 
VP of Quality & Compliance
Event Speaker Company: 
Arbor Vita Corporation, Inc.
Event Speaker Bio: 

Krishna Ghosh, Ph.D. VP of Quality and Compliance program at Arbor Vita Corporation, Inc. developing Avian Flu and HPV Diagnostic based on a novel “PDZ” protein technology platform. She has over 18 years of experience in Product development, manufacturing /Operation/ Business Management, Quality Assurance, Quality control and Regulatory Affairs in Biotech and Pharmaceutical companies. In the past 8 years she has primarily focused her attention in emerging Gene Expression and Microfluidic based technologies. In –depth knowledge of Blood Lancing and Glucose Monitoring Devices and the regulatory challenges associated these technologies. Her knowledge in GMP, GLP,GCP and Quality Systems Regulations and Program Management techniques have earned recognition in the Biotech community. She established a Quality/Regulatory and Program Management department at Agilent Technologies Life Sciences Division and validated two manufacturing facilities along with all the processes to successfully launch Commercial Microarrays as a Gene Expression Technology. She spearheaded two strategic initiatives with FDA and NIST to develop regulatory guidelines for this new technology and develop Scanner Standards for NIST.

She is an advisory member at FDA and NIST, and she was awarded the "AWIS Professional Award" in 2003 for her outstanding work in mentoring scientists and students to transition from academics to industry. She has presented talks in several scientific committees with the latest developments in regulatory initiatives and guidelines at FDA. She was nominated as a "Distinguished Executive VP of Operations" in 2006 Cambridge's Who's Who Directory during her tenure with Genemed Biotechnologies Inc. She has been assisting several Bay Area Biotech/ Diagnostics/ Pharmaceutical startup companies to build an effective and robust Quality & Compliant management Systems aligned with Business / Operational excellence infrastructure for successful commercial launches of products with new technologies.

Event Details
Cost: 
$0 - Free
Event Details: 

Recently, The European Commission released the latest and final recommendations for changes to the Medical Device Directive. While the reforms fall short of what some had hoped for, there are significant changes nonetheless and regardless of what type of device you manufacture. The various proposed changes will be presented and discussed during this talk.

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