COURSE OVERVIEW:

The meaning of this course lies in the establishment of a legally and technically compliant laboratory environment that operates within the complex web of international regulations. As globalization synchronizes industrial requirements, laboratory professionals must move beyond simple testing and understand the legal architectures that govern data validity and safety. This program provides the foundational legal and technical framework required to navigate the diverse codes and standards that ensure laboratory results are recognized and accepted across international borders.

The scope of the training addresses the hierarchy of regulatory bodies, including ISO, ASTM, and specific regional mandates like the GCC Standardization Organization (GSO). It covers the fundamental difference between voluntary standards and mandatory regulations, focusing on how to integrate disparate requirements into a single, cohesive Quality Management System. Participants will explore the evolution of the "New Approach" to regulation and the role of the laboratory in supporting compliance with environmental, health, and consumer protection laws.

The coverage includes a detailed investigation into the relationship between ISO/IEC 17025 and industry-specific codes such as GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice). The course emphasizes the interpretation of "Shall" versus "Should" in regulatory documentation and the management of "Regulatory Audits" from governmental bodies. By mastering these frameworks, participants will be able to align their laboratory operations with global best practices, mitigate legal liabilities, and enhance the commercial reputation of their organization.

COURSE OBJECTIVES:

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

• Define the core principles of international and regional regulatory frameworks.
• Distinguish between "Accreditation" and "Certification" in a laboratory context.
• Interpret the legal language used in ISO and ASTM standards.
• Align laboratory operations with the GSO and other regional requirements.
• Implement the core requirements of Good Laboratory Practice (GLP).
• Integrate GMP requirements into an analytical testing environment.
• Navigate the "Hazard Communication Standard" and its regulatory impacts.
• Manage the transition between old and revised versions of industry codes.
• Conduct a "Gap Analysis" against newly introduced regulatory standards.
• Document a "Statement of Conformity" for industrial testing results.
• Prepare the laboratory for unannounced inspections from regulatory bodies.
• Evaluate the impact of "Third Party" standards on laboratory liability.

TARGET AUDIENCE:

This course is intended for Laboratory Directors, Quality Managers, Regulatory Affairs Officers, and Senior Compliance Specialists.

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.