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Preparing for fda
1. Live Webinar on : Preparingfor FDA Inspectionand Handlingthe Consequences Thursday,
May 31, 2012 duration : 12:00 to 01:30 PMEST
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Who will benefit
Clinical Research managers
Project Managers
Clinical Research Associates
Monitors
Quality Assurance Professionals
Research coordinators
Clinical investigators
Description
We will review the latest inspection statistics released
from FDA, discuss how to prepare for an FDA
Inspection, discuss how to repsond to an FDA
Inspection and discuss the possible outcomes of an
FDA Inspection that has resulted in significant findings
and/or citations.
Why should you Attend :
· In 2010 under CDRH, CDER and CBER divisions
alone, FDA classified 1,097 Sponsor, Site and IRB
Inspections. Of those Inspections 9% or ~ 66 of the
Clinical Investigator Inspections, 6% or ~ 15 of the IRB
Inspections and 12% or ~ 15 of the Sponsor/Monitor
Inspections were categorized as "Official Action
Indicated". 45% of Clinical Investigator, 50% of IRB
and 38% of Sponsor/Monitor Inspections were
categorized as "Voluntary Action Indicated" being
required. Because FDA Inspections are part of doing
business and getting products to market, Clinical
Investigators, Sponsors and IRBs should not only be
prepared to handle an FDA Inspection but alsobe
prepared to follow-up on findings, following the
inpsection
Areas Covered in the Session:
2. purchase formats
$189 One Dial In - One
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$249 One Dial In - Unlimited
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Conference room/Meeting room.
Note : Only One Dial In Allowed)
$289 On Demand (Recording
available within 48 hrs after the
completion of the webinar)
$349 Get Training CD
More Trainings
- Preparing for an FDA Inspection.
- Discussion on receiving and responding to 483s and
warning letters.
- Discussion on what actions the FDA can take over and
beyond issuinga 483 or Warning Letter.
About Speaker:
Lee Truax-Bellows has an extensive background in the
pharmaceutical and medical device industries, having
worked for both industry and a CRO as a Regulatory
Consultant Monitor, Medical Communications
Associate, Senior Quality Auditor, Senior Trainer and
Project Manager. Lee has been involved in regulated
research for over 20 plus years and specializes in
product development, GCP auditing, and training on
regulated research and Good Clinical Practice.
Lee is a founder, President and CEO of Norwich
Clinical Research Associates Ltd. (NCRA). NCRA is a
clinical contract research organization (CRO) based in
upstate NY. NCRA has been providing clinical
research expertise in medical device, pharmaceutical,
and nutraceutical development since 1994. NCRA
provides full service CRO services such as monitoring,
auditing, technical writing, data management,
biometrics and product development consulting.
Lee is active in the Association of Clinical Research
Professionals (ACRP) and Society of Quality Assurance
(SQA).
