Modules

Module 1: Fundamentals of Laboratory Quality Assurance

• Introduction to QA in laboratory settings.
• Key components of a laboratory quality management system (LQMS).
• Overview of ISO/IEC 170210, GLP, and GMP standards.
• Hands-on Exercise: Identifying QA gaps in laboratory procedures.

Module 2: Laboratory Accreditation and Compliance

• Accreditation requirements under ISO/IEC 170210.
• Ensuring compliance with Good Laboratory Practices (GLP).
• Risk management in laboratory QA systems.
• Hands-on Exercise: Preparing laboratory documents for accreditation.

Module 3: Internal Audits and Quality Control Practices

• Principles of internal laboratory audits.
• Corrective and Preventive Actions (CAPA).
• Proficiency testing and interlaboratory comparisons.
• Hands-on Exercise: Conducting a mock internal audit.

Module 4: Data Integrity and Reporting in Laboratories

• Ensuring data accuracy, consistency, and traceability.
• Electronic vs. manual record-keeping.
• Compliance with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete).
• Hands-on Exercise: Reviewing and validating laboratory reports.

Module 5: Future Trends and Best Practices in Laboratory QA

• Digital transformation and automation in laboratory QA.
• Case studies on quality assurance failures and improvements.
• Ethical considerations in laboratory data reporting.
• Hands-on Exercise: Developing a laboratory QA improvement plan.