8/3/2019 Writing and Maintaining Quality Standard Operating Procedures

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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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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

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About GlobalCompliancePanel

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