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Understanding and Navigating the Evolving FDA Regulatory Process in order to Achieve Optimal Market Launch and Avoid Compliance Pitfalls

Wednesday, August 1, 2012 from 7:30 AM to 9:30 AM (PDT)

Costa Mesa, United States

Understanding and Navigating the Evolving FDA Regulator...

Ticket Information

Ticket Type Sales End Price Fee Quantity
OCTANe Members & Sponsors Ended Free $0.00
General Public Ended $25.00 $0.00
OCTANe Membership and Free Admission Ended $300.00 $0.00

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Share Understanding and Navigating the Evolving FDA Regulatory Process in order to Achieve Optimal Market Launch and Avoid Compliance Pitfalls

Event Details

Program Summary:

The FDA regulations for medical devices have been in place for over 35 years, but are changing more rapidly now than ever before.  These days FDA expects quality to be pervasive throughout an organization and not relegated to simple manufacturing process controls.   The Agency is also revising the 510(k) regulatory submission process, a fundamental pathway for new product clearances.  It is imperative that device developers, manufacturers and distributors understand these changing regulations and implement the necessary controls and processes.  This presentation will provide a high level overview of the FDA regulatory process, from testing through submission and clearance/approval, as well as the quality system requirements, both under the regulations and from a best business practices perspective.

 

Program Themes:

  • FDA Medical Device Classification and Submission Process
  • FDA Quality System Requirements – Pre and Post Marketing
  • Regulatory Harmonization in a Global Economy

 

Bill Greenrose - Director in Governance Regulatory & Risk Strategies, Deloitte & Touche LLP

Bill Greenrose is a Director in Deloitte & Touche’s Governance Regulatory and Risk Strategies practice. He has over 30 years of experience in FDA regulated and Life Science industries in the areas of regulatory, clinical, quality assurance, quality control, laboratory, R&D, manufacturing, core lab, compliance and corporate/operations.

With his broad and deep knowledge and experience, Bill assists clients globally in developing strategies concerning regulatory approach and submissions (e.g. pre-IDE, IDE, 510(k) PMA, CE Mark, Technical File), quality systems (e.g. QSR, GxP, ISO 13485, ISO 9001), regulatory compliance (proactive and reactive, e.g. Warning Letter/FDA 483 response), auditing and training in a highly regulated environment. Bill has consulted for various national and international pharmaceutical, medical device, and biotechnology companies and is internationally recognized for his subject matter knowledge concerning regulatory compliance, quality systems, and computerized systems validation (e.g. 21 CFR 11). Bill has presented around the world on regulatory strategy and compliance and has trained Korean FDA investigators on FDA inspection techniques.

 

Breakfast will be provided.

Have questions about Understanding and Navigating the Evolving FDA Regulatory Process in order to Achieve Optimal Market Launch and Avoid Compliance Pitfalls? Contact the organizer

When & Where

695 Town Center Drive, Suite 1200
Doheny/Strands Conference Room, 4th Floor
Costa Mesa, 92626

Wednesday, August 1, 2012 from 7:30 AM to 9:30 AM (PDT)


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