Strategies to establish and manage a compliant contemporary microbiology laboratory


Instructor: Chitra Edwin
Product ID: 701458

  • Duration: 60 Min
This Microbiology testing Lab design training webinar will discuss the comprehensive design strategies in accordance to FDA, ICH, CDC mandates so as to ensure successful audit of quality compliance and bio hazard protection.
Last Recorded Date: Oct-2009


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Why should you Attend:
An element of risk is prevalent in a microbiological testing environment due to safety hazards posed not only by potential infectious testing materials, but also by the chemicals and radio-isotopic reagents required for the analysis of these samples. A key requirement of a microbiology laboratory is the execution of specialized safety practices, and containment measures to minimize or ideally eliminate the exposure of hazardous agents to laboratory personnel directly involved in laboratory operations.

The design and establishment of a testing facility and materials handling are impacted by stringent guidelines defined by regulatory agencies including the Food and Drug Administration (FDA), International Conference on Harmonization (ICH), and Centers for Disease Control (CDC). In addition, periodic internal and external monitoring of the facilities is necessitated to ensure the enforcement and continuity of quality policies. The management systems impacted for regulatory scrutiny broadly comprise good laboratory practices and technique, bio-safety handling practices, standard operating procedures, methods validation, organizational structure, qualifications and training of personnel, safety equipment validation and performance, reagent certification, document control including the recording, reporting, and archiving of information, and laboratory information management systems (LIMS).

This webinar will provide comprehensive strategies for the design of a microbiology testing laboratory in accordance with current global regulatory (FDA, ICH and CDC) directives, and the management of these mandates to ensure successful audits for quality compliance and biological hazard protection. Target areas for potential compliance failures, and relevant case studies will also be addressed.

Areas Covered in the seminar:

This webinar will be a comprehensive overview of Auditing of a Microbiology Laboratory for QC compliance.

  • The following topics will be addressed:.
    • Design of a Microbiology Testing Laboratory.
    • Biosafety Levels.
    • Laboratory practices and safety.
    • Safety Equipment.
    • Documentation.
    • Inspections.
    • Corrective and Preventive Actions.

Who Will Benefit:
This webinar is highly recommended for personnel in microbiology testing laboratories at contract research organizations, biotechnology, pharmaceutical and device industry. The material will be beneficial for professionals with microbiology training and experience. Areas of relevance include:
  • R&D
  • Regulatory Affairs
  • Quality Control and Quality Assurance
  • Manufacturing

The employees that this information would be pertinent include:

  • Microbiology Analysts
  • Laboratory Supervisors and Directors, Managers
  • QC Auditors and Inspectors
  • Microbiological testing analysts
  • Regulatory Affairs
  • Quality Control and Quality Assurance
  • Training
  • Consultants

Instructor Profile:
Chitra Edwin, Ph.D., the founder of Biotechnology Consulting Solutions, Ltd. has over 15 years of product development and management experience in start-ups, mid-sized and large biotechnology and diagnostic companies. She has managed projects from concept, R&D through manufacturing transfer, and has been involved in the development of commercial products for AIDS and cancer. She has successfully established fully functional GLP and CLIA compliant laboratories, managed multidisciplinary project teams, executed technology transfers, and orchestrated collaborations between national and international professionals.

Dr. Edwin has managed pre-clinical evaluations of potential therapeutic biologics and vaccines. 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 industry. Dr. Edwin has provided consulting services to start-ups, Fortune 500 and healthcare consulting companies focused in biologics and devices. Consulting services have been provided in areas of product development, technology assessment/ technology transfer, due diligence, pre-clinical testing, proof of concept studies, regulatory affairs/ regulatory strategy, project management, and the preparation of SBIR grants, technical/ medical reports and scientific reviews.

Dr. Edwin obtained her Ph.D. in Medical Microbiology and Immunology from the University of Minnesota followed by post-doctoral training at the Harvard Medical School and the Dana Farber Cancer Institute. She has obtained Regulatory Affairs board certification (RAC) from the Regulatory Affairs Professional Society. She is an Adjunct Associate Professor of Pharmaceutical Sciences, College of Pharmacy; University of Cincinnati, and the Director of the Capstone project.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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