Live Webinar
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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
Duration: 60 Minutes
Instructor: Dr. Chitra Edwin
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
Dr. Chitra Edwin Founder, Biotechnology Consulting Solutions, Ltd.
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.
Areas Covered in the Session: 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
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Process to create an SOP A Standard SOP template; Header and Footer Defining a process map or flow chart to accompany the insertion of information.
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Content - (1) General SOP information, and (2) SOP specific for equipment, bio-analytical procedures, and clinical research. Ensuring that the content meets recommended regulatory guidelines The process for an approved SOP, author, reviewer, and approver. SOP deviations Strategies to ensure that personnel are following the SOPs Organizing, cataloging and archiving SOPs Personnel Training and documentation Access control of SOPs
Dr. Chitra Edwin, Ph.D., RAC. has significant product development and management experience in biotechnology and diagnostic companies. She has managed projects 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
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SOP revisions, updated versions and retirement FDA and EU requirements Examples: FDA Form 483s and Warning Letters
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Who Will Benefit: l l
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Quality Assurance/ Quality Control Managers Laboratory Technologists/ Analysts involved in Product Development Senior Management (CEO, COO, Directors) Regulatory Affairs professionals GLP , cGMP and GCP Managers, Supervisors Pre-clinical Laboratory Testing Personnel Clinical Trial Professionals, IRB administrators
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