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EVENT DATE
Jan 2017
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Webinar on The New FDA-Product Approval, Inspection, and Enforcement

Overview

Overview:
The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration.

The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting manufacturers under very tight response timelines.

Areas Covered in the seminar:
    The "new" FDA organization and mission
    Enforcement changes- increased inspection
    Enforcement Changes-new expectations
    Manufacturers responsibilities for FDA-483s
    Manufacturers responsibilities in Warning Letter situations
    Pre-market changes-Human Factors
    New Risk Management Guidance

Who Will Benefit:
    Regulatory Managers
    Quality Managers
    Product Managers
    Project Managers

Speaker Profile:
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501066LIVE?channel=mailer&camp=Webinar&AdGroup=eventsinamerica_Jan_2017_SEO
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Notes:
Sponsorship Details:

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