Overview :
Method validation and method verification are two distinct procedures required to combat food bioterrorism/ comply with ISO/IEC Standard 17025:2005 for a microbiological media laboratory accreditation and microbiological contamination control in pharmaceutical clean rooms.
Unfortunately, the two terms are often used interchangeably with serious consequences in bioterrorism food and FDA inspection readiness checklist.
Why Should You Attend :
Without a clear understanding of the different analytical approaches for verification and validation, laboratories often end up doing more unnecessary, costly work, with little benefit for FDACGMP compliance, FDA audit training, FDAGMP compliance or for FDA good documentation practices.
Very often the inappropriate analytical strategy used is unacceptable to meet the requirements for FDA validation training/ accreditation and the effort needs to be repeated. Learn to do the microbiology media preparation, right the 1st time!
Areas Covered In This Webinar :
Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses.
Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005.
Understanding these differences is essential for developing appropriate strategies for assessing a method鈥檚 fitness for purpose.
This webinar will not only address the semantics, but will also discuss the appropriate analytical and statistical approaches to achieving successful verification and validation studies.
Learning Objectives :
Method performance characteristics
Measuring and Monitoring Analytical competency
Food Categories and Food Types
Analytical requirements for Validation of Quantitative Methods
Analytical requirements for Validation of Qualitative Methods
Analytical requirements for Verification of Quantitative Methods
Analytical requirements for Verification of Qualitative Methods
Fitness for purpose
Who Will Benefit :
Microbiological Bench Analysts in Food, Water and Pharmaceutical Laboratories
QA Managers
Laboratory Managers/ Supervisors
QC Practitioners
Level:
Intermediate
Speakers Profile :
Michael Brodsky Michael has been an Environmental Microbiologist for more than 42 years. He is a Past President of the Ontario Food Protection Association (OFPA), the International Association for Food Protection (IAFP) and AOAC International. He serves as Chair for the AOAC Expert Review Committee for Microbiology, as a scientific reviewer in Microbiology for the AOAC OMA and the AOAC Research Institute, as a reviewer for Standard Method for the Examination of Water and Wastewater and as a chapter editor on QA for the Compendium of Methods in Microbiology. He is also a lead auditor/assessor in microbiology for the Canadian Association for Laboratory Accreditation (CALA) and is Vice-chair of the CALA Board of Directors.
Method validation and method verification are two distinct procedures required to combat food bioterrorism/ comply with ISO/IEC Standard 17025:2005 for a microbiological media laboratory accreditation and microbiological contamination control in pharmaceutical clean rooms.
Unfortunately, the two terms are often used interchangeably with serious consequences in bioterrorism food and FDA inspection readiness checklist.
Why Should You Attend :
Without a clear understanding of the different analytical approaches for verification and validation, laboratories often end up doing more unnecessary, costly work, with little benefit for FDACGMP compliance, FDA audit training, FDAGMP compliance or for FDA good documentation practices.
Very often the inappropriate analytical strategy used is unacceptable to meet the requirements for FDA validation training/ accreditation and the effort needs to be repeated. Learn to do the microbiology media preparation, right the 1st time!
Areas Covered In This Webinar :
Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses.
Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005.
Understanding these differences is essential for developing appropriate strategies for assessing a method鈥檚 fitness for purpose.
This webinar will not only address the semantics, but will also discuss the appropriate analytical and statistical approaches to achieving successful verification and validation studies.
Learning Objectives :
Method performance characteristics
Measuring and Monitoring Analytical competency
Food Categories and Food Types
Analytical requirements for Validation of Quantitative Methods
Analytical requirements for Validation of Qualitative Methods
Analytical requirements for Verification of Quantitative Methods
Analytical requirements for Verification of Qualitative Methods
Fitness for purpose
Who Will Benefit :
Microbiological Bench Analysts in Food, Water and Pharmaceutical Laboratories
QA Managers
Laboratory Managers/ Supervisors
QC Practitioners
Level:
Intermediate
Speakers Profile :
Michael Brodsky Michael has been an Environmental Microbiologist for more than 42 years. He is a Past President of the Ontario Food Protection Association (OFPA), the International Association for Food Protection (IAFP) and AOAC International. He serves as Chair for the AOAC Expert Review Committee for Microbiology, as a scientific reviewer in Microbiology for the AOAC OMA and the AOAC Research Institute, as a reviewer for Standard Method for the Examination of Water and Wastewater and as a chapter editor on QA for the Compendium of Methods in Microbiology. He is also a lead auditor/assessor in microbiology for the Canadian Association for Laboratory Accreditation (CALA) and is Vice-chair of the CALA Board of Directors.
