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Dr. Chitra Edwin
Instructor Dr. Chitra Edwin
Product Id 600663
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

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

Overview:

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.

Why should you attend: Poorly crafted and incomplete Standard Operating Procedures (SOPs) are the nemesis resulting in FDA 483 observations and Warning Letter citations. Implementing an organized SOP system will ensure that these deficiencies are eliminated. Adequate training and communication within an organization with all levels of personnel will enforce complaint documentation of procedural details necessary to generate accurate and reproducible results. Instilling the importance of accuracy and attention to detail during training sessions will be a motivator for personnel to adhere to approved SOPs while fulfilling their routine responsibilities that are impacted by regulatory compliance.

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:

  • When an SOP is required
  • 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.
  • 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
  • SOP revisions, updated versions and retirement
  • FDA and EU requirements
  • Examples: FDA Form 483s and Warning Letters
Who will benefit:
  • 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

Speaker Profile
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.

Dr. Edwin has held management positions at Chiron Corporation (currently Siemens Healthcare) and MassBiologics (formerly the Massachusetts Biologic Laboratories). Dr. Edwin is an Adjunct Associate Professor of Pharmaceutical Sciences, Director of the Capstone project, College of Pharmacy, University of Cincinnati where she teaches regulatory compliance and pharmaceutical product development, and mentors students in the Master’s in Drug Development program. She offered a training course in GMP as part of the Global Training Network, WHO Department of Vaccines and Biologicals, and frequently conducts webinars on product development and regulatory compliance for reputed e-learning companies.

Dr. Edwin has been a consultant for the biotechnology, and diagnostics industry since 2005, and founded Biotechnology Consulting Solutions, Ltd. in 2006 (www.biotechconsultsolns.com). Dr. Edwin obtained her Ph.D. in Medical Microbiology and Immunology from the University of Minnesota, followed by post-doctoral training in Infectious Diseases at the Harvard Medical School and the Dana Farber Cancer Institute. She has secured Regulatory Affairs board certification (RAC). She is a Review Board member of Opus Institutional Review Board (IRB).

She was a co-founder and President of the Graduate Women in Science (Massachusetts chapter). Memberships have been held in Sigma Xi; Scientific Research Society, ASM, AAAS, RAPS, MIT Forum, GWIS, the Foreign Policy Leadership Council of Greater Cincinnati, BioOhio and Kindervelt.

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