This microbiology laboratory training will provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance, test failures and resolution of audit findings.
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.
The following topics will be addressed:
Areas of Relevance include:
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.
Who Will Benefit:
This webinar is highly recommended for personnel in microbiology testing laboratories at contract research organizations, the medical device, pharmaceutical and biotechnology industry. The material will be beneficial for beginners, and also serve as a refresher for experienced professionals.Areas of Relevance include:
- R&D
- Regulatory Affairs
- Quality Control and Quality Assurance
- Manufacturing
- The employees that this information would be pertinent include:
- Microbiology Analysts
- Laboratory Supervisors and Directors, Managers
- QC Auditors and Inspectors
- Microbiological testing analysts
- Regulatory Affairs
- Quality Control and Quality Assurance
- Training
- Consultants
- Auditors and Inspectors
Course Provider
Chitra Edwin,
