Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations

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Avoiding FDA 483 Observations by Identifying the Root Cause of
Deviations


Course "Avoiding FDA 483 Observations by Identifying the Root
Cause of Deviations" has been pre-approved by RAPS as

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eligible for up to 1.5 credits towards a participant's RAC
recertification upon full completion.
Date & Time:
Instructor Profile:
Tuesday, June 19, 2012
10:00 AM PDT | 01:00 PM EDT
John G. Lanese
Duration: 90 Minutes
Instructor: John G. Lanese
President, Lanese Group,
Inc.
Location: Online
Price : $245.00 (for one participant)
John G. (Jerry) Lanese, Ph.D.
CMC is the president of The Lanese
Overview:
Group, Inc, an independent
Recent Consent Decrees have included requirements that the firm
consulting service provider that
develop and implement systems that result in timely and complete
specializes in Quality Systems and
investigations of deviations and corrective and preventive actions
Laboratory Controls. Jerry has
taught at the college level and
that address the root cause of deviations.
worked in various Quality Control
and Quality Assurance roles in small
FDA 483 and Warning letter observations identify inadequate
and large pharmaceutical firms. For
investigations and follow-up. This webinar addresses adequate
the last 15 years he has consulted in
investigationofdeviations.Participants will obtain a greater insight
a wide range of projects from
into effective investigations and ways to identify the root cause and
consent decree remedial actions with
prevent a similar deviation in the future.
large pharmaceutical firms to
systems development for a small
component manufacturer. He has
TheinvestigationofdeviationsisclearlyaUSFDAexpectation.The
lectured throughout the world to
international regulatory expectation for a structured approach to
clients and for major seminar
investigations that lead to corrective actions and preventive actions
providers. He was voted the best
is clearly stated in ICH Q10, Pharmaceutical Quality System, and
presenter of the year in 2001 by the
supported in the FDA Guidance to the Industry, Quality System
Institute of Validation Technology. In
Approach to Pharmaceutical CGMP Regulations. This course will
2008 he received the Kenneth
include a discussion of the Deviation System, what should be
Chapman Industry Recognition
investigated and the level of investigation. Several tools that will
Award. ...more
lead to the identification of the root cause will be discussed. These
include: process mapping, brainstorming, cause analysis, cause and
effect and the 5 Whys. The investigation system will be integrated
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Your Necessity is our Priority
Why should you attend:
Recent Consent Decrees have included requirements that the firm
develop and implement systems that result in timely and complete
investigations of deviations and corrective and preventive actions


that address the root cause of deviations. FDA 483 and Warning
letter observations identify inadequate investigations and follow-up.
This webinar addresses adequate investigation of
deviations.Participantswillobtainagreaterinsight into effective
investigations and ways to identify the root cause and prevent a
similar deviation in the future.
Areas Covered in the Session:
l
What should be investigated - Complaints, audit observations,
deviations, discrepancies, calibration out-of-tolerances
l
FDA expectations for investigations
l
The investigation-problem resolution process - understand the
problem, identify possible causes, data collection, data
analysis, root cause identification, root cause elimination,
solution implementation, verify success
l
Tools for understanding the process - mapping, critical
incident, performance matrix
l
Tools for understanding the possible causes - brainstorming,
is/is not, nominal group
l
Tools for narrowing the investigation to the most probable
cause - data collection, data analysis
l
Determining the root cause - cause and effect, Fault tree, 5
Whys.

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l
Corrective action
l
Preventive Action
l
Verification
Click here to register for this webinar
Who Will Benefit:
The following individuals and disciplines will benefit from this
webinar:
l
QA document reviewers
l
QA personnel responsible for reviewing investigations reports
l
QA personnel responsible for the deviation and investigations
systems
l
Quality and Operations personnel responsible for
investigations
l
Personnel from all units responsible for initiating investigations
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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