4-Hour Virtual Training: Auditing the Microbiology Laboratory

This training program on Auditing the Microbiology Laboratory will focus on sampling, sample control, and chain-of-custody. It will detail contract services - qualifying them and reviewing/monitoring their performance and results; and method validation, tech transfer, and inter-laboratory comparison testing of unknowns.

Why Should You Attend:

This 4-hour session (including a midpoint 15-minute bio-break and 15 minutes at the end of the session for Q&A) will focus on the topics a comprehensive microbiology laboratory audit covers as well as how auditors or regulatory agency inspectors obtain evidence (of noncompliance or risk thereof), how they think and the data trails they follow. This knowledge will help you and your company maintain continual improvement of the microbiology laboratory, its facilities, utilities, equipment, documents, records, personnel, and become and remain audit-prepared and audit-friendly.

You should attend this webinar if:

• You are a full-time CGMP compliance/quality auditor
• You are assisting the regular auditor(s) in auditing your own company or a contract microbiology lab
• You work in the microbiology lab and periodically self-inspect it against CGMPs and SOPs
• You, a microbiology lab supervisor/manager, will host future audits or regulatory agency inspections

Areas Covered in the Webinar:

• Operational definitions
• Audit preparation
• Sampling, sample control, and chain-of-custody
• Document control, record-keeping, and data integrity
• Employee credentials and training
• Contract service providers
• Laboratory controls (i.e., laboratory design/set-up, appearance, environmental controls, ongoing activities)
• Method validation, compendial method suitability testing/verification, method tech transfer, and lab certification
• critical laboratory reagents
• Reference standards microbes, biological indicator spores, and endotoxin
• Equipment, instruments and their qualification, calibration, and maintenance
• Non-sterile product testing for total bioburden, specified as well as objectionable microorganisms
• Sterility testing
• Bacterial endotoxin testing (BET) via LAL
• Virus, mycoplasma, bacteriophage, and other adventitious agent assays
• Water testing (other than BET)
• Contamination control of facilities (specifically sanitization)
• Environmental monitoring, water monitoring, personnel monitoring
• Isolates ID testing and librarying (with cryopreservation)
• Laboratory investigations of microbiological data deviations (MDDs)

Who Will Benefit:

This webinar will provide auditing tools as well as useful compliance knowledge to the following individuals inside and outside the life sciences industries:

• Compliance auditors
• Quality auditors
• Quality control microbiology analysts
• Supervisors, managers, and directors
• Contract lab owners and managers
• Quality assurance and compliance management
• Consultants
• Regulatory agency investigators
• Anyone who wants to gain familiarity with pharmaceutical microbiology