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

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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:
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
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
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
When an SOP is required
collaborations between national and
Process to create an SOP
international professionals. Dr.
A Standard SOP template; Header and Footer
Edwin's responsibilities have included
Defining a process map or flow chart to accompany the

the pre-clinical development of
insertion of information.
therapeutic biologics, vaccines and
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
Ensuring that the content meets recommended regulatory
contractual service agreements, and
organized professional meetings with
The process for an approved SOP, author, reviewer, and
representatives from academia and
the bioscience industry. ...more
SOP deviations
Strategies to ensure that personnel are following the SOPs
Organizing, cataloging and archiving SOPs
Suggest a Topic
More Webinars
Personnel Training and documentation
Access control of SOPs
Your Necessity is our Priority
SOP revisions, updated versions and retirement
FDA and EU requirements
Examples: FDA Form 483s and Warning Letters
Click here to register for this webinar

Who Will Benefit:
Quality Assurance/ Quality Control Managers
Laboratory Technologists/ Analysts involved in Product
Senior Management (CEO, COO, Directors)
Regulatory Affairs professionals
GLP , cGMP and GCP Managers, Supervisors
Pre-clinical Laboratory Testing Personnel
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,

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