Auditing the Microbiology Laboratory

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.