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Writing and Maintaining Quality Standard Operating Procedures (SOPs) to Guarantee FDA Compliance

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Document Description
A cogent understanding and thorough knowledge of the regulations for SOPs is a necessity for product development and clinical testing organizations with the goal of agency approval, and product commercialization.
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  • Added: February, 21st 2012
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  • Tags: online training, standard operating procedures, sops, guarantee fda compliance, fda form 483s, warning letters, eu requirements, sop revisions
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Live Webinar on

Writing and Maintaining Quality Standard Operating Procedures
(SOPs) to Guarantee FDA Compliance

Date & Time:


Thursday, March 15, 2012
10:00 AM PST | 01:00 PM EST

Register Now

Duration: 60 Minutes
Instructor: Dr. Chitra Edwin
Location: Online
Price : $245.00 (for one participant)
Instructor Profile:
Overview:
Dr. Chitra Edwin
A cogent understanding and thorough knowledge of the regulations
Founder, Biotechnology
for SOPs is a necessity for product development and clinical testing
Consulting Solutions, Ltd.
organizations with the goal of agency approval, and product
commercialization.
Dr. Chitra Edwin, Ph.D., RAC. has
significant product development and
Information flow should be elucidated in lucid, comprehensible steps
management experience in
that can be easily understood by all levels of personnel from
biotechnology and diagnostic
companies. She has managed
inexperiencedanalyststomanagers.Measuresshouldbe
projects from concept, R&D through
implemented to ensure that the personnel and the inspectors are
manufacturing transfer, and has
allied with the understanding, interpretations the expectations for
been a key member in the
complaint SOPs.
development of products for AIDS
and cancer that have obtained FDA
approval and are commercially
Areas Covered in the Session:
available. She has successfully
This webinar will provide comprehensive guidelines for the best
established and managed GLP and
practice in the preparation and maintenance of SOPs. Detailed
CLIA compliant laboratories,
information will be provided on the following topics:
managed multidisciplinary project
teams, executed technology
transfers, and orchestrated
l
When an SOP is required
collaborations between national and
l
Process to create an SOP
international professionals. Dr.
l
A Standard SOP template; Header and Footer
Edwin's responsibilities have included
l
Defining a process map or flow chart to accompany the

the pre-clinical development of
insertion of information.
therapeutic biologics, vaccines and
l
Content - (1) General SOP information, and (2) SOP specific for
diagnostics. She has functioned as a
equipment, bio-analytical procedures, and clinical research.
facilitator between academia and
industry that culminated in
l
Ensuring that the content meets recommended regulatory
contractual service agreements, and
guidelines
organized professional meetings with
l
The process for an approved SOP, author, reviewer, and
representatives from academia and
approver.
the bioscience industry. ...more
l
SOP deviations
l
Strategies to ensure that personnel are following the SOPs
l
Organizing, cataloging and archiving SOPs
Suggest a Topic
More Webinars
l
Personnel Training and documentation
l
Access control of SOPs
Your Necessity is our Priority
l
SOP revisions, updated versions and retirement
l
FDA and EU requirements
l
Examples: FDA Form 483s and Warning Letters
Click here to register for this webinar

Who Will Benefit:
l
Quality Assurance/ Quality Control Managers
l
Laboratory Technologists/ Analysts involved in Product
Development
l
Senior Management (CEO, COO, Directors)
l
Regulatory Affairs professionals
l
GLP , cGMP and GCP Managers, Supervisors
l
Pre-clinical Laboratory Testing Personnel
l
Clinical Trial Professionals, IRB administrators
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
1000 N West Street Suite,
1200 Wilmington DE 19801
Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

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