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8/3/2019 Writing and Maintaining Quality Standard Operating Procedures
http://slidepdf.com/reader/full/writing-and-maintaining-quality-standard-operating-procedures 1/2
Live Webinar on
Writing and Maintaining Quality Standard Operating Procedures(SOPs) to Guarantee FDA Compliance
Date & Time:
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.
Information flow should be elucidated in lucid, comprehensible steps
that can be easily understood by all levels of personnel from
inexperienced analysts to managers. Measures should be
implemented to ensure that the personnel and the inspectors are
allied with the understanding, interpretations the expectations for
complaint SOPs.
This webinar will provide comprehensive guidelines for the best
practice in the preparation and maintenance of SOPs. Detailed
information will be provided on the following topics:
l When an SOP is required
l Process to create an SOP
l A Standard SOP template; Header and Footer
l
Defining a process map or flow chart to accompany theinsertion of information.
l Content - (1) General SOP information, and (2) SOP specific for
equipment, bio-analytical procedures, and clinical research.
l Ensuring that the content meets recommended regulatory
guidelines
l The process for an approved SOP, author, reviewer, and
approver.
l SOP deviations
l Strategies to ensure that personnel are following the SOPs
l Organizing, cataloging and archiving SOPs
l Personnel Training and documentation
l Access control of SOPs
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 w ebinar
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
T hu rs day, Mar ch 15 , 2 01 2 1 0:0 0 A M P ST | 0 1:0 0 P M EST
Duration: 60 Minutes Instructor: Dr. Chitra Edwin
Location: Online Price : $245.00 (for one participant)
Overview:
Areas Covered in the Session:
Who Will Benefit:
Register Now
Instructor Profile:
Dr. Chitra Edwin, Ph.D., RAC. has
significant product development and
management experience in
biotechnology and diagnostic
companies. She has managedprojects from concept, R&D through
manufacturing transfer, and has
been a key member in the
development of products for AIDS
and cancer that have obtained FDA
approval and are commercially
available. She has successfully
established and managed GLP and
CLIA compliant laboratories,
managed multidisciplinary project
teams, executed technology
transfers, and orchestrated
collaborations between national and
international professionals. Dr.
Edwin’ s responsibilities have included
the pre-clinical development of therapeutic biologics, vaccines and
diagnostics. She has functioned as a
facilitator between academia and
industry that culminated in
contractual service agreements, and
organized professional meetings with
representatives from academia and
the bioscience industry. ...more
Dr. Chitra Edw in
Founder, Biotechnology
Consulting Solutions, Ltd.
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Y o u r N e c e ss i t y i s o u r P r i o r i t y
It would be really nice if you can circulate this mail to all your deserving colleagues who can immen sely
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
8/3/2019 Writing and Maintaining Quality Standard Operating Procedures
http://slidepdf.com/reader/full/writing-and-maintaining-quality-standard-operating-procedures 2/2
About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
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