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Auditing the QC Microbiology Laboratory for FDA Compliance

 
  October 02, 2012  
     
 
ComplianceOnline, Online Event
2012-10-17


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 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.

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.
Event Details:
 
Date:                    October 17, 2012
Time:                    10:00 AM-11:15 AM PDT
Cost:                    $299 per attendee per computer terminal
Registration:         SIgn-Up on-line now.  Add to your shopping cart.
 
 
Organized by: ComplianceOnline
Invited Speakers: Chitra Edwin, Ph.D., RAC. has significant 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 a key member in the development of products for AIDS and cancer that have obtained regulatory approval.
 
Deadline for Abstracts: 2012-10-17
 
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701364?channel=hummolgen
E-mail: referral@complianceonline.com
 
   
 
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