Creating Successful Device History Record and keep FDA happy in the process

Live Webinar on

Creating Successful Device History Record and keep FDA happy in the
process
Date & Time:


Wednesday, June 15, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Instructor: Nancy Duarte-
Duration: 60 Minutes
Lonnroth
Price : $245.00 (for one
Location: Online
Instructor Profile:
participant)

Nancy Duarte-Lonnroth
Director, Quality and
Overview:
Regulatory Affairs, Celestica
Overview: Many companies are confident that their record keeping
for the firm's device history records is compliant to the Quality
Nancy, is the Director of Quality &
System regulation, yet when the FDA comes calling, FDA 483 DHR
Regulatory Affairs, Healthcare
cites are written and warning letters, seizures or worse ensue.
responsible for global coordination of

Celestica's Healthcare Quality,
Regulatory and FDA compliance.
Learning Objectives:
Nancy is Quality and Regulatory
expert with fifteen years experience
in regulatory affairs, quality
l
Learn what FDA expects and will request from you during your
DHR review.
systems, compliance, clinical quality,
validation, auditing, quality control,
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How QSIT inspections related to record keeping is performed
data management systems, post
by FDA.
market surveillance, supplier
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How Change can affect DHRs.
management and regulatory
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Learn what constitutes a good DHR procedure.
compliance in the areas of
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Learn how risk management fits into DHR compliance.
bio/pharmaceuticals, medical
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Learn how to better audit quality record systems.
devices and combination products.
Nancy has contributed to the success


of both venture and public
Areas Covered in the Session:
companies, establishing a track
record of successfully achieving
timely global regulatory approvals,
l
Introduction
initiating and effectively managing
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Guidance documents/ QS regulation
preclinical and clinical investigations
l
Major FDA 483 points
and developing and maintaining
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Trends in FDA warning letters
effective and compliant quality
l
Determining best practice for the DHR audit
systems in various healthcare
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Be prepared by knowing how to conduct a MORE thorough
sectors. ...more
record audit
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FDA 483 point issuance prevention
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Your Necessity is our Priority
Who Will Benefit:
l
Senior executives of pharmaceutical and device firms
l
Quality Unit Vice Presidents

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Directors and Managers
l
Vice presidents
l
Directors and Managers of operations
l
Quality Engineers and field Auditors
l
Regulatory and Compliance Management
l
Consultants

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
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