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  HUM-MOLGEN -> Events -> Courses and Workshops  

Auditing the Microbiology Laboratory

  September 28, 2012  
ComplianceOnline, Online Event

Why Should You Attend:

You should attend this webinar if:

  1. You are a full-time compliance and quality auditor
  2. you may be called upon to assist one or a team of auditors going into your own company’s or a contracted microbiology lab
  3. you may be called upon to perform a department self-inspection
  4. you may be a member of microbiology laboratory supervision or management who will host future audits and regulatory inspections

This 90-minute session will focus on the topics a proper microbiology lab audit covers as well as how auditors obtain evidence. You will learn how and FDA auditor/inspector thinks and use that knowledge to help your microbiology laboratory and its equipment, documents, records, personnel, etc. become audit-friendly.

Areas Covered in the Seminar:

  • Sampling and Sample Control.
  • Employee Training and Contract Services.
  • Method Validation.
  • Reagents and Media.
  • Reference Standards and Control Cultures.
  • Equipment and Instruments.
  • Document Control and Record-Keeping.
  • Laboratory Controls.
  • Non-sterile Product Testing.
  • Sterility Testing and Sterility Test Isolators.
  • Endotoxin Testing.
  • Environmental Monitoring.
  • Microorganism Isolates and Identification.
Event Details:
Date:                     October 11, 2012
Time:                    10:00 AM-11:30 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: Bob Seltzer, has more than 25 years in R&D, Process Development, and Quality Assurance/Compliance in pharmaceuticals, medical devices, food, dietary supplements, and cosmetics industries.
Deadline for Abstracts: 2012-10-11
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702480?channel=hummolgen
E-mail: referral@complianceonline.com
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