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Validation: A Necessary EVIL
Alison Ethridge, MSFSHID FAS - Southeast
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Validation in Forensic Laboratories
A. Guided Validation Support Services
Validation Support Service Offerings for Human Identity Testing
B. Comprehensive Validation Support Services
C. Validation Competency Training
D. Implementation Support Services
Additional Resources
Agenda
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Validation in Forensic Laboratories
Validation in Genetic Identity and Forensic Laboratories
Internal validation MUST be performed by forensic testing laboratories whenever:
Setting up a new testing laboratory Introducing a new forensic test method Replacing an existing test method
Internal validation must demonstrate:
Robustness Reliability Reproducibility
Validation is an essential part of any forensic QA system
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Forensic and Human Identity Validation Services
Significantly Accelerate & Assure Implementation
QIAGEN can support your validation requirements, whether you have:
Limited staff resources Limited time Limited experience in validation studies Large validation projects
Using QIAGEN’s validation support services can drastically reduce validation time:
Reducing time to implement new procedures Realizing the benefits of new techniques earlier Helping to achieve accreditation deadlines
QIAGEN services give you assurance that your system will be ‘online’ faster
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Forensic and Human Identity Validation Services
Fulfilling Standard Requirements
QIAGEN’s validation support services are designed to meet the requirements of:
FBIThe FBI‘s Quality Assurance Standards for Forensic DNA Testing Laboratories (2011).
ISO/IEC 17025:2005General requirements for the competence of testing and calibration laboratories
ISO/IEC 17025:2005
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Validation in Forensic Laboratories
A. Guided Validation Support Services
Validation Support Service Offerings for Human Identity Testing
B. Comprehensive Validation Support Services
C. Validation Competency Training
D. Implementation Support Services
Additional Resources
Agenda
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QIAGEN Forensic Validation Services
Guided Validation Services
Comprehensive Validation Services
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QIAGEN Forensic Validation Services
Guided Validation Services
All travel and labor for QIAGEN Specialist(s)
• QIAGEN consumables
• Experimental design consultation and validation templates
• Introduction to best lab practices
• An introduction to instrument hands-on-operation and cleaning
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QIAGEN Forensic Validation Services
Comprehensive Validation Service
• All travel and labor charges for the QIAGEN Validation Team
• All laboratory bench work
• QIAGEN consumables necessary for completion of the validation studies
• Data analysis using GeneMapper® ID or GeneMapper® IDX
• An internal validation summary report
• All electronic data returned to the laboratory
• Support of laboratory data review
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QIAGEN specific offerings….
Extraction Quant Amp CE/data Summary
QIAGEN Customized Forensic Validation Services
QIAcube DWP
EZ1 Advanced XL
QIAcube
QIAsymphony
QuantiplexPro Investigator 24plex QS
Investigator 24plex GO!
+ Any other extraction, quant, PCR systems…
Supported Products
QIAgilityQIAgility
QIAgility
+ And multiple units
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What else can we do for you?
QIAGEN Forensic Validation Services
Validation Competency
Training
Implementation Support Services
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QIAGEN Forensic Validation Services
Validation Competency Training includes:
• Training the laboratory DNA staff on QIAGEN instrumentation and chemistry
• A review of the validation design plan and resultant data (may be included if applicable to the laboratory)
• Hands-on-learning and seminar based communications
• A Certificate of Attendance
Implementation Support Services include:
• All travel and labor charges for the QIAGEN implementation support team
• On-site consultation for the QIAGEN user laboratory members which may include:
• Protocol design & instrument setup
• Workflow ideas & best practices • Shared data & history
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Grant Writing, NIJ bids, sole sourcing information
QIAGEN personalized support for grant writing and NIJ bids
Work with QIAGEN Forensic Application Support Team to:
Assist your laboratory with writing the specific grant language
Provide sole source language for QIAGEN chemistry, services or instrumentation needed
Provide quote(s) for the grant for the validation support service that is required
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Validation in Forensic Laboratories
A. Guided Validation Support Services
Validation Support Service Offerings for Human Identity Testing
B. Comprehensive Validation Support Services
C. Validation Competency Training
D. Implementation Support Services
Additional Resources
Agenda
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Performance Checks
Performance Checks• All travel and labor charges for the
QIAGEN implementation support team
• All laboratory bench work
• QIAGEN consumables necessary for completion of the performance check
• Data analysis using GeneMapper® ID or GeneMapper® IDX
• An internal performance check summary report
• All electronic data returned to the laboratory
• Support of laboratory data review
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QIAgility Software
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NEW & Improved QIAgility Software
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Why change?
- Current version of software no longer supported
- New features to fit your needs
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No More Sample Banks!
What’s new?
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Sample Import via CSV
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Output plate – well assignment
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Sample Dilution Schemes
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Want a demo? Call us!
QIAGEN FAS Team Contact Information
HawaiiAlaska
North EastSim Wintz
Email: [email protected]: 951-265-7832
North EastAmber McManus
Email: [email protected]: 302-423-4742
South EastAlison Ethridge
Email: [email protected]: 205-382-7029
South WestMeredith Turnbough
Email: [email protected]
Phone: 480-432-8034