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Auditing the QC Microbiology Laboratory for FDA Compliance

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					                 Auditing the QC Microbiology Laboratory for FDA Compliance

                                December 09, Thursday 10:00 AM PST | 01:00 PM EST

Why Should You Attend:

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 moni-
tors standard operating procedures, methods validation, organizational structure, qualifications and training of person-
nel, 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, resolu-
tion of audit findings, and examples of issuance of 483s and warning letters.


Date: December 09, Thursday 2010
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Min
Instructor: Chitra Edwin
Location: Your office or conference room (no need to travel!)                                                  Chitra Edwin


    Register Now


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

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

  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.


   Registration Information:

      * Register Online. Use your American Express, Visa or MasterCard.
      * For more than one attendee get 20% off on the price of additional attendee.
     * Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
     * Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
      * Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.



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DOCUMENT INFO
Description: This Microbiology Laboratory training 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