COURSE OVERVIEW:

The meaning of this course centers on the absolute necessity of trust in the digital records generated by chromatography. Data Integrity is the hallmark of a compliant laboratory, ensuring that the "story" told by a chromatogram is complete, consistent, and accurate. This course provides the technical and regulatory expertise to validate Chromatography Data Systems (CDS), ensuring they act as an impenetrable fortress for analytical results against manipulation or accidental loss.

The scope of the training focuses on the ALCOA+ principles and their specific application to gas and liquid chromatography workflows. It addresses the validation of the entire data lifecycle, from the initial integration parameters to the final electronic signature and archival. Participants will explore the critical role of audit trails, the management of "Orphan Data," and the technical controls required to prevent the common pitfalls of "Peak Shaving" or "Integration into Baseline" that can lead to regulatory citations.

The coverage includes a detailed investigation into 21 CFR Part 11 and EU Annex 11 compliance, focusing on the practical steps of software validation (IQ/OQ/PQ). The course emphasizes the detection of data integrity "red flags" and the implementation of robust standard operating procedures for data review. By mastering these compliance frameworks, laboratory professionals can ensure that their chromatography data is audit-ready and meets the highest global standards of scientific ethics.

COURSE OBJECTIVES:

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

• Apply ALCOA+ principles to chromatographic data management.
• Validate Chromatography Data Systems (CDS) using GAMP 5 guidelines.
• Implement robust audit trail review procedures for all analytical runs.
• Manage user access levels to ensure segregation of duties in the CDS.
• Detect and prevent common data manipulation techniques in chromatography.
• Configure "Static" and "Dynamic" data storage to ensure records are "Original."
• Develop SOPs for the use of manual integration and its justification.
• Perform risk-based validation of CDS software updates and patches.
• Manage the archival and retrieval of long-term electronic records.
• Conduct internal data integrity audits of the chromatography laboratory.
• Ensure compliance with 21 CFR Part 11 and EU Annex 11.
• Formulate a "Data Integrity Master Plan" for the laboratory facility.

TARGET AUDIENCE:

This course is intended for Chromatography Specialists, Quality Assurance Officers, CDS Administrators, Laboratory Managers, and Regulatory Compliance Auditors.

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.