Effective ethics and data integrity plans are becoming more and more important to consistently generating good data. The TNI Standard has a number of requirements for establishing an effective data integrity program to both protect the organizations reputation and help assure the quality and integrity of the data generated. What systems, practices, and procedures are needed to meet the current standards and more importantly to support an effective management system? What does management of a laboratory and field sample collection and measurement organizations need to do to ensure an effective program? How do you audit to this part of the standard?
This webcast provides an introduction and basic understanding of what goes into implementing an effective data integrity plan. This webcast includes a review of the Standard provisions, clarifications of language and explanations of the requirements. Discussion will also include suggestions on potential implementation and tools to monitor progress and undertake a "proactive prevention" process. The webcast is designed to suggest how an effective data integrity program can fold into a laboratory's management system without having two management systems. The material presented is designed to assist management in developing and implementing a detection and prevention program through systems, practices, procedures, simple tools and communication. Opportunities for interaction are provided through polling questions, problem solving and question/answer.
The importance of clear and accurate records. What constitutes a non-conformance and an out-of-control condition. How and when to initiate a Corrective Action. Why SOPs are important and when they need to be revised. How to be alert and sensitive to actions by staff that may be improper, illegal or in violation of ethics policies and practices. How to identify occurrences of departures from the management system or from the procedures for performing tests and how to initiate actions to prevent or minimize such departures. The procedures used to protect laboratory customers' confidential information, including procedures for protecting the electronic storage and transmission of results. How to recognize activities that could diminish confidence in the competence, impartiality, judgement or operational integrity of the laboratory. The relevance and importance of his or her activities and how they contribute achieving the objectives of the management system. The organization's mission and its relationship to the critical need for honesty and full disclosure in all analytical reporting, and how and when to report data integrity issues. How to conduct all data integrity issue investigations in a confidential manner until they are completed. How to establish and maintain a documented data integrity system.
Quality Managers, Technical Managers, Laboratory Managers, Laboratory Assessors, Laboratory Owners
Data Integrity Specialist
3 hours
Jack Farrell
Jack Farrell has more than 40 years of experience in the environmental industry as an analyst, QA professional, technical and general manager of small, medium and large commercial laboratories. He is an experienced environmental manager, laboratory chemist, trainer, and auditor. Mr. Farrell holds degrees in Biological Sciences (Microbiology) and Chemistry and is a professional trainer, consultant and third party assessor for a number of state and federal regulators. Jack Farrell is a Senior Environmental Analyst, President and Founder of Analytical Excellence, Inc. (AEX). Since its inception in 1993, AEX has been an independent strictly confidential consulting firm specializing in environmental laboratory operations, analysis and matters concerning the generation of analytical data to support effective compliance decision-making and aspects of litigation. AEX's clientele consist of well-known small and large laboratory companies, instrument manufacturers, engineering firms, state and federal regulatory agencies and legal practice firms.
Jack Farrell has more than 40 years of experience in the environmental industry as an analyst, QA professional, technical and general manager of small, medium and large commercial laboratories. He is an experienced environmental manager, laboratory chemist, trainer, and auditor. Mr. Farrell holds degrees in Biological Sciences (Microbiology) and Chemistry and is a professional trainer, consultant and third party assessor for a number of state and federal regulators.
Jack Farrell is a Senior Environmental Analyst, President and Founder of Analytical Excellence, Inc. (AEX). Since its inception in 1993, AEX has been an independent strictly confidential consulting firm specializing in environmental laboratory operations, analysis and matters concerning the generation of analytical data to support effective compliance decision-making and aspects of litigation. AEX's clientele consist of well-known small and large laboratory companies, instrument manufacturers, engineering firms, state and federal regulatory agencies and legal practice firms.
