COURSE OVERVIEW:

The meaning of this course lies in the synthesis of Good Laboratory Practice (GLP) and rigorous statistical measurement to create a holistic framework for data defensibility. In the modern regulatory landscape, simply following a procedure is not enough; laboratories must also quantify the level of confidence in every result they produce. This program provides the advanced skills required to merge the administrative discipline of GLP with the mathematical complexity of measurement uncertainty, ensuring that laboratory outputs are robust enough for legal, clinical, and industrial scrutiny.

The scope of the training addresses the high-level management of laboratory "Quality Systems" through the lens of OECD and FDA GLP principles. It covers the lifecycle of a scientific study, from the initial protocol design and personnel authorization to the final archiving of raw data. Simultaneously, participants will delve into the advanced estimation of measurement uncertainty, exploring how various sources of variation—such as sampling, environmental flux, and instrument drift—contribute to the total error budget of an analytical measurement.

The coverage includes a comprehensive investigation into the role of the Quality Assurance Unit (QAU), the management of "Study Plans," and the implementation of multi-component uncertainty models. The course emphasizes the interpretation of "Decision Rules" and "Statements of Conformity," which are critical for determining if a product meets its specifications. By mastering these integrated compliance frameworks, participants will be able to lead their organizations toward a state of "Total Quality," where every analytical number is supported by both a valid process and a quantified confidence interval.

COURSE OBJECTIVES:

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

• Integrate GLP principles with measurement uncertainty requirements.
• Manage the lifecycle of a GLP study from protocol to final report.
• Identify and quantify all significant sources of measurement error.
• Utilize the "Law of Propagation of Uncertainty" for complex models.
• Establish the role and independence of the Quality Assurance Unit.
• Calculate "Expanded Uncertainty" using appropriate coverage factors.
• Develop "Decision Rules" based on the "Guard Band" principle.
• Manage raw data and electronic records according to ALCOA+ standards.
• Perform "Impact Assessments" for deviations in GLP environments.
• Report uncertainty and conformity statements on analytical reports.
• Lead internal audits of integrated GLP and uncertainty systems.
• Defend analytical results during high-level regulatory inspections.

TARGET AUDIENCE:

This course is intended for Study Directors, Quality Assurance Officers, Principal Investigators, and Senior Scientists in GLP-regulated laboratories.

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.