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Auditing the QC Microbiology Laboratory for FDA Compliance

Webinars - Auditing the QC Microbiology Laboratory for FDA Compliance

By : Compliance Online

Date : 2011

Location : United States US / Palo Alto

Video 01h 16m
Description :

This training provides a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection.

Keywords :

FDA Compliance, QC Microbiology Laboratory, FDA, LIMS, Compliance training, Web Seminar, E-learning

Microbiology analytic testing is designed for the detection of pathogenic and non-pathogenic microorganisms that are prevalent in materials subject to human and animal exposure, and in the environment. In order to ensure safety and hygiene the testing procedures and the laboratories where they are performed are impacted by defined regulatory guidelines at non-clinical testing and manufacturing facilities.


An important aspect of compliance includes periodic internal and external inspections to ensure the enforcement of quality policies. These regulatory requirements broadly comprise management systems that enforce rules and monitors standard operating procedures, methods validation, organizational structure, qualifications and training of personnel, facilities, biosafety precautions, equipment validation and performance, reagent certification, document control including the recording, reporting, and archiving of information, and laboratory information management systems (LIMS). Preparation for inspections is a fundamental aspect of routine operations.


This webinar based on FDA guidelines will provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance, test failures, resolution of audit findings, and examples of issuance of 483s and warning letters.

Who Will Benefit:

This webinar is highly recommended for personnel in microbiology testing laboratories at contract research organizations, the medical device, pharmaceutical and biotechnology industry. The material will be beneficial for beginners, and also serve as a refresher for experienced professionals.


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:.
    • Infrastructure of a Microbiology Testing Laboratory.
    • Test Methods and Validation.
    • Equipment.
    • Documentation.
    • Preparation for inspections.
    • Corrective Actions.
    • Preventive Actions.



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
  • Auditors and Inspectors



Instructor Profile:

Chitra Edwin, Ph.D. 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 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.


Recorded webinar and reference materials will be available on your account after purchase.

Auditing the QC Microbiology Laboratory for FDA Compliance

Product Type : On Demand Webinar

Author : Chitra Edwin

Video 01h 16m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria