U.S. FDA's Strategic Priorities for 2013 and Beyond - Webinar By GlobalCompliancePanel
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Toll Free Number: 800-447-9407
RAPS Approved Webinar on
U.S. FDA's Strategic Priorities for 2013 and Beyond
Date: Wednesday, January 9, 2013 Time: 10:00 AM PST | 01:00 PM EST
Course "U.S. FDA's Strategic Priorities for 2013 and Duration: 90 Minutes
Beyond" has been pre-approved by RAPS as eligible
Instructor: John E Lincoln
for up to 1.5 credits towards a participant's RAC
recertification upon full completion. Location: Online
John E Lincoln
Consultant, Medical device and Register Now
Regulatory affairs,
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to
implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In
addition, he has successfully designed, written and run all types of process, equipment and software
qualifications/validations, ...more
Overview:
This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with
emphasis on 2013. Such a review will focus on the broad range of issues a company's senior
management and QA-RA need to consider in their annual Management Review of their existing
quality management system.
This review takes on added urgency as a result of the stated intent of the Agency to get tougher
across the board in its expectations for the medical industry and what the FDA and industry need
to do internally.
Areas Covered in the Session:
l The FDA's "Strategic Priorities" for 2013 and Beyond
l Tougher Regulatory Science - What "Better Science"
Really Means
l Device, Pharmaceutical and Biological Issues
l General cGMP Issues - Strengthened Compliance
l Major Pending 510(k) Changes
l FDA's Life Cycle View Requirements
l Safety - Integrity of Global Supply Chain
l Heightened Supplier Issues
l FDA Clearance - Approval Only the Beginning -
Product "Lifecycles"
Who Will Benefit:
l Senior management in Suggest a Topic
Drugs, Devices, Biologics,
More Webinars
Dietary Supplements
l QA
l RA
l R&D
l Engineering Click here to
l Production
register for this
l Operations
l Consultants webinar
It would be really nice if you can circulate this mail to all your deserving colleagues who can
immensely benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel
About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model
for online compliance training by creating a single window of learning opportunities for compliance
professionals & providing a forum for expert speakers/panelists to render their services through simplified
online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of
best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance
professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all
sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal
ensures a secure & cost effective online environment and also support your E-learning and development
on/through our website. Keep track of all webinars arranged for your industry through notifications & event
calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.
GlobalCompliancePanel
www.globalcompliancepanel.com
Livermore Common, Fremont,
CA 94539, USA
Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
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