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Managing a Data Integrity Investigation
August 29-30, 2023
11:00am-2:00pm Eastern
Webinar
Course Description:
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
Participants will:
- 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
Learning Objectives:
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
Intended Audience:
This course is designed for Quality Managers, Laboratory and Field Managers, Corporate Management
Cost:
$125 per person for TNI members
$140 per person for TNI non-members
$600 per group of 5-10 students at same location for TNI members
$675 per group of 5-10 students at same location for TNI non-members
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.
Format:
Webinar Start Date:
Tuesday 29th August 2023, 11:00am EDT Length:
6 hours CEUs: 0.6 
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Presented By:
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). |
The NELAC Institute
develop consensus standards for use by TNI's programs. This group has a support role in assisting other programs with activities such as guidance and standards interpretation.
fosters the generation of data of known and documented quality is through the National Environmental Laboratory Accreditation Program, or NELAP. The purpose of this program is to establish and implement a program for the accreditation of environmental laboratories.
is to establish and maintain a national PT program to support TNI’s National Environmental Laboratory Accreditation Program, and other activities.
Field Activities Program (NEFAP) Executive Committee is to establish and implement an accreditation program for field sampling and measurement organizations (FSMOs).
Audit Sample Program is to develop consensus standards for the manufacture and analysis of audit samples for source emission testing.
on a variety of topics of interest to the environmental measurement community. TNI also hosts two regularly scheduled meetings per year, typically in January and August. Both are a week long and involve open meetings of TNI committees as well as training courses and other special sessions.