COURSE OVERVIEW:

The meaning of this course lies in the technical rigor required to ensure that every analytical result is a true reflection of physical reality, backed by an unbroken chain of comparisons. In high-stakes testing environments, such as environmental monitoring or forensic toxicology, the integrity of the data is the laboratory’s most valuable asset. This program provides the deep-dive expertise necessary to validate the entire measurement process, from the initial calibration of the instrument to the final verification of the reported number.

The scope of the training focuses on the integration of metrological traceability with the practical demands of testing integrity. It addresses the challenges of "Indirect Traceability" for non-physical quantities and the validation of qualitative versus quantitative testing methods. Participants will explore the mechanics of "Data Governance," ensuring that every electronic and manual record is attributable, legible, and contemporaneous, thereby meeting the highest standards of international accreditation.

The coverage includes a comprehensive investigation into the "Decision Rule" in conformity assessment and the management of measurement risk. The course emphasizes the mathematical relationship between traceability and uncertainty, providing the skills to build robust validation models for complex multi-parameter tests. By mastering these integrity protocols, participants will be able to lead their laboratories toward a state of "Total Technical Assurance," where every result is scientifically sound and legally indestructible.

COURSE OBJECTIVES:

After completion of this course, the participants will be able to:

• Define the relationship between traceability, uncertainty, and data integrity.
• Implement the ALCOA+ principles in daily laboratory operations.
• Design a traceability strategy for complex analytical instrumentation.
• Validate the integrity of raw data collected from automated systems.
• Apply decision rules to conformity assessments with confidence.
• Perform a "Measurement Systems Analysis" (MSA) to identify error sources.
• Establish "Fitness for Purpose" criteria for analytical methods.
• Manage the lifecycle of data from initial capture to long-term archiving.
• Audit the technical integrity of subcontracted laboratory services.
• Utilize Proficiency Testing (PT) results as a validation of traceability.
• Evaluate the impact of "Reference Standard" drift on test results.
• Lead a culture of scientific honesty and technical transparency.

TARGET AUDIENCE:

This course is intended for Quality Assurance Managers, Technical Leads, Senior Analysts, and Auditors working in ISO 17025 or GLP-regulated environments.

TRAINING COURSE METHODOLOGY:

A highly interactive combination of lectures, discussion sessions, and case studies will be employed to maximize the transfer of information, knowledge, and experience. The course will be intensive, practical, and highly interactive. The sessions will start by raising the most relevant questions and motivating everybody to find the right answers. The attendants will also be encouraged to raise more of their questions and to share in developing the right answers using their analysis and experience. There will also be some indoor experiential activities to enhance the learning experience. Course material will be provided in PowerPoint, with necessary animations, learning videos, and general discussions.

The course participants shall be evaluated before, during, and at the end of the course.

COURSE CERTIFICATE:

National Consultant Centre for Training LLC (NCC) will issue an Attendance Certificate to all participants completing a minimum of 80% of the total attendance time requirement.