Program Overview
The immersive program designed to equip professionals with the knowledge, tools, and frameworks necessary to achieve operational and quality excellence in laboratory environments. With a blend of conceptual insights, real-world case studies, hands-on simulations, and actionable takeaways, the program focuses on balancing regulatory compliance (e.g., GLP, ISO 17025) with efficiency through Lean Six Sigma principles and digital transformation. Participants will work through actual problem-solving exercises such as root cause analysis, workflow redesign, and CAPA planning, and will leave with templates and checklists that can be directly applied to their workplace challenges.
Features
- Understand the integration of operational excellence frameworks with regulatory compliance in labs.
- Apply Lean Six Sigma tools to identify and reduce inefficiencies in lab workflows.
- Conduct root cause analysis and develop effective CAPA strategies for lab incidents.
- Draft an actionable plan to enhance traceability, turnaround time, and data integrity
Target audiences
- Laboratory managers
- QA/QC professionals
- Analytical scientists
- Operations leads and Compliance officers
Curriculum
- 4 Sections
- 16 Lessons
- 1 Day
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- Foundations of Laboratory Excellence5
- 1.1Operational Excellence (OpEx) vs. Quality Assurance (QA): Balancing efficiency with compliance
- 1.2Good Laboratory Practices (GLP): Regulatory frameworks (ISO/IEC 17025, FDA 21 CFR Part 58)
- 1.3Lean Six Sigma in Labs: Reducing waste, optimizing workflows (e.g., TAT reduction)
- 1.4Key Terms: LIMS (Laboratory Information Management Systems), QC/QA protocols, CAPA (Corrective and Preventive Action), OOS (Out-of-Specification)
- 1.5Terminology Quiz: Match jargon (e.g., “Action Limit,” “LOD”) to definitions
- Situational Awareness & Real-World Challenges5
- 2.1Digital Transformation in Labs: Example: Burjeel Holdings’ shift from manual processes to automated sample management (reduced errors by 40%)
- 2.2Integrating LIMS for end-to-end traceability
- 2.3Regulatory Non-Compliance: Example: A pharma lab’s failed audit due to missing metadata in raw data logs
- 2.4Exercise: Participants identify gaps in a simulated audit report
- 2.5How would you handle a sudden OOS result during a critical batch release?
- Problem-Solving Session3
- 3.1Root Cause Analysis (RCA): Tool: Fishbone Diagram (Ishikawa) to dissect a lab incident (e.g., contamination)
- 3.2Optimizing Turnaround Time (TAT): Simulation: Redesign workflows using Lean principles (e.g., reducing reagent wait times)
- 3.3Leverage predictive maintenance for equipment to avoid unplanned downtime
- Key Inisghts3
Instructor
