Managing a Data Integrity Investigation
Every laboratory receives questions about the content of their reports or observations about laboratory activities. Sometimes a simple explanation is needed concerning the use of data qualifiers or verifying reported values. Any communication that questions a laboratory activity or product must be taken seriously even when it is from the curmudgeon who routinely calls with seemingly insignificant issues. Concerns or observations about a laboratory’s activities can originate from clients, whistleblowers (internal or external), or from internal or external audits.
Each concern, no matter how trivial, must be investigated. In most cases, the response can be straightforward. However, irregularities in the documentation or records may imply a data integrity issue that must be addressed.
Expected Benefit of Training
- Better understand what constitutes a data integrity violation and the process for investigating deliberate data integrity violations
- Understand the basic process for conducting an initial investigation including:
- How to gather information and evidence
- How, who and when to notify or inform
- How to take disciplinary action
- How to work through initial corrections
- How to perform Root Cause Analysis
- Be able to avoid future problems by
- Conducting a data integrity refresher course for all laboratory staff and
- Ensuring the appropriate corrective actions have been taken
By the end of the training, participants will:
- Understand how Data Integrity is incorporated in the Quality System
- Know how to identify deliberate data integrity violations
- Know how to organize an investigation of deliberate data integrity violation
- Determining extent of problem
- Assembling and reviewing the raw data
- Interviewing analyst(s) and other personnel
- Determining and taking appropriate disciplinary actions
- Know how and whom to notify (and when)
- Knows how to work through corrections
- Reprocessing data
- Reissuing reports
- Know how to perform Root Cause Analysis to determine final corrective actions
- Knows how to improve the Quality Management System by
- Implementing and evaluating appropriate corrective actions
- Scheduling a data integrity refresher training for staff
- Implementing any needed changes to the data integrity program
This course is designed for Quality Managers, Laboratory and Field Managers, Corporate Management
$150 for TNI members
$165 for non-members
Group rates are available: Each purchased webcast is to be viewed by only one student. If you would like multiple viewers, separate purchases must be made. A group rate of $725 for TNI members or $800 for non-members is available for groups of 5-10 students at a single location. Click here to purchase this webcast at the group rate.
TNI Members: you must be logged-in to the website to receive the member rate.
No certificates are automatically provided with this training. A Certificate of Completion (CoC) ($30 per person) or Certificate of Attendance (CoA) ($20 per person) may be purchased during or after registration or webcast purchase. A passing score of at least 70% must be received on the exam in order to receive CEUs and a CoC. Scores of less than 70% will receive a Certificate of Attendance at no reduced fee. For a CoA you will not need to take the quiz and you will not receive CEUs. To receive your certificate, contact Paul Junio at [email protected] with date of purchase and date of training completion. See FAQs for additional information.
About Webcasts: Upon receipt of your payment, you will receive a special link by e-mail to watch the webcast on your computer. The link is time-limited: you will have full access to the webcast and any associated handouts for 6 months after receipt of payment, at which time the link will expire. Webcasts cannot be downloaded; they are intended for viewing on your computer only during the 6-month window. If you have any questions, please contact Ilona Taunton at [email protected].
Silky and John Labie
About the Presenter:
The principals of ELCAT, LLC collectively have over 70 years of experience in laboratory and field quality management. ELCAT, LLC provides extensive training of laboratory and field personnel in sampling techniques, quality management and training that addresses the requirements of the National Environmental Laboratory Accreditation Program (NELAP). It performs readiness audits for laboratories who desire to improve their quality system for the purposes of NELAP accreditation. ELCAT presents training and presentations on quality-related topics such as method performance, data integrity, corrective and preventive actions, root-cause analysis, data usability, and the role of quality managers. The company is used exclusively by the University of Florida Center for Training, Research & Education for Environmental Occupations (TREEO) for all off-site training of field personnel. It is regularly asked to provide presentations at the Florida Society of Environmental Analysts (FSEA) meetings. ELCAT, LLC has also provided training and presentations for New York City, the State of Virginia, and The NELAC Institute (TNI).