Auditing the QC Microbiology Laboratory for FDA Compliance – Key Concepts, GMP Issues, and Best Audit Practices

The quality control of a microbiology laboratory plays a critical role in any quality systems control program. The FDA has continued to focus on activities that occur in the QC microbiology laboratory when conducting inspections. Significant deviations in the laboratory can result in regulatory compliance issues such as warning letters and 483 citations. Auditing can provide valuable information and data on the compliance status of your microbiology laboratory. Through the use of various auditing tools, one can develop metrics to track and trend results directly from the lab.

During this live and interactive BenAstrum web training course, Dr. Frank S. Kohn will look at the main FDA concerns pertaining to auditing and GMP issues in a typical microbiology laboratory. An expert’s view will be presented regarding what to look for and how to perform external audits on contract laboratories and internal audits on your own laboratories.

Learning Benefits:

• Key auditing concepts pertaining to a laboratory
• How to perform a risk-based audit
• What to look for in microbiology validation programs
• Assess training models used in the microbiology laboratory
• Determine GLP & GMP compliance levels
• Know what critical compliance issues to look for in the laboratory
• Learn what to include in any laboratory audit

Who Can Benefit:

• QA/QC personnel, including Supervisors, Managers and Directors
• Manufacturing personnel, including Supervisors, Managers and Directors
• Regulatory Affairs personnel
• Validation personnel
• R&D personnel
• Engineering personnel