Biofabrication - Bio009- Formation Six Sigma Yellow Belt pour les superviseurs de la production et le personnel d’AQ / CQ dans la fabrication de vaccins et de produits pharmaceutiques

Objectives

1. Lead teams through structured problem-solving processes: Dive deeper into DMAIC (Define, Measure, Analyze, Improve, Control) methodology, gaining a more nuanced understanding of its application in the context of pharmaceutical and vaccine production. Learn how to lead teams through structured problem-solving processes.

2. Comprehensive Process Mapping: Master the art of detailed process mapping, allowing you to identify intricate workflows, interdependencies, and critical points in pharmaceutical and vaccine manufacturing. Leverage advanced process mapping to optimize production efficiency.

3. Advanced Root Cause Analysis Techniques: Explore advanced techniques for root cause analysis, equipping you to identify and address complex issues affecting quality and compliance. Develop skills to lead teams in tackling multifaceted challenges in pharmaceutical and vaccine production using: Fishbone Diagram (Ishikawa), 5 Whys Technique, Fault Tree Analysis (FTA), Pareto Analysis, and Change Analysis, to assess the impact of changes within the production processes. Understand how to identify and manage potential unintended consequences, ensuring smooth transitions and minimizing disruptions.

4. In-Depth Statistical Tools: Delve into advanced statistical tools such as statistical process control (SPC) and hypothesis testing. Understand how to utilize these tools for in-depth analysis, ensuring precise monitoring and control of pharmaceutical and vaccine production processes.

5. Failure Mode Effects and Criticality Analysis (FMECA):Learn to apply Failure Mode Effects and Criticality Analysis to systematically evaluate potential failure modes, their effects, and criticality. Understand how FMECA enhances risk assessment and guides prioritization of corrective actions in pharmaceutical and vaccine production.

6. Advanced Control Charts and Variability Management: Explore advanced applications of control charts for managing variability. Understand how to interpret complex chart data and implement strategic control measures to ensure a stable and predictable production environment.

Who Should Attend:

- Production supervisors and QA/QC staff in pharmaceutical and vaccine manufacturing

- Those seeking a deeper understanding of Six Sigma for enhanced leadership in the production environment.

Elevate your leadership in pharmaceutical and vaccine production and lead your team toward excellence in quality, efficiency, and compliance.