Postgraduate Advanced Management of the Quality Laboratory

Program Overview

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The Postgraduate Advanced Management of the Quality Laboratory program, offered by IQS at the Barcelona campus, empowers professionals with the skills and competencies to lead multidisciplinary teams and implement Good Laboratory Practices in analytical laboratory processes, meeting ISO 17025 standards. The program combines in-person and online sessions, providing a flexible learning experience compatible with professional commitments. Upon completion, participants receive a Diploma of University Specialization in Advanced Management of the Quality Laboratory, preparing them for leadership roles in quality laboratories across various industries.

Program Outline

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Postgraduate Advanced Management of the Quality Laboratory | IQS

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Degree Overview:

The Postgraduate Advanced Management of the Quality Laboratory program is a proprietary degree from Ramon Llull University (URL) offered at the Barcelona campus. It is designed for professionals with experience in analytical laboratory processes.

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Objectives:

The program aims to develop participants' competencies and skills to:

• Lead multidisciplinary teams: Utilizing methodologies and tools for quality project management.
• Implement Good Laboratory Practices (GLP): Integrating risk analysis into key laboratory activities.
• Utilize risk analysis tools: Applicable to the laboratory setting.
• Identify and define KPIs: For use in a dashboard.
• Demonstrate the competence of the analytical laboratory: Under ISO 17025 standards.
• Estimate measurement uncertainty: Using appropriate methodology.
• Select and conduct intercomparison exercises.

• Plan and conduct internal audits.

• Prepare for audits by clients or regulatory authorities.

• Track changes, corrective actions, and preventive actions.

• Manage deviations and CAPAs.

• Create an Analytical Quality by Design (AQBD) model.

• Use statistical tools for data and trend analysis.

• Analyze stability study data according to ICH Q1E.

• Create a Lean-Kaizen team and implement the methodology in the laboratory.

• Use various Lean-Kaizen tools and overcome resistance to change.

• Implement Data Integrity in chemistry and microbiology laboratories.

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Outline:

The program is delivered in a blended format, combining in-person sessions on campus or at company visits with synchronous online sessions via video conferencing.

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Modules:

• Leadership and Project Management:
• Team Leadership Skills:
Team dynamics, strategic and people leadership, effective interpersonal communication and assertiveness, negotiation and influence, conflict prevention, management, and resolution.
• Project Financial Management: Fundamentals of financial management and information flows, analysis of financial statements (balance sheet, P&L, treasury), project cost and budget control, economic viability of a project/company, profitability analysis, and investment decisions.
• Project Direction and Planning: Defining projects, project vs. operations, project life cycle, project initiation, project charter and KPIs, planning, scope, Gantt chart and human resources, execution, control, and team management, closure, documentation, and project delivery.
• Good Laboratory Practices:
• Implementing Good Practices and Integrating Risk Analysis:
ISO 17025, GLP, and ISO 9001 standards, good documentation practices (BPD), risk analysis (risk ranking, ATCC, FMEA), quality KPIs in the laboratory and dashboard, outsourcing services and analysis, management of OOS, OOT, and deviations.
• Accreditation of Analytical Laboratories:
• Demonstrating Laboratory Competence and Estimating Measurement Uncertainty:
Laboratory accreditation process, estimation of measurement uncertainty, establishing acceptance criteria, intercomparison exercises.
• Quality Audits in Analytical Laboratories:
• Planning and Conducting Internal, Client, or Regulatory Authority Audits:
Preparation and management of internal audits, passing certification and accreditation audits, auditing outsourced laboratories, CAPA management, and deviation management.
• Laboratory Data Analysis:
• Analyzing Data from In-Process Controls, Final Product, and Stability Studies:
Excel and Minitab applications for the control laboratory, inferential statistics, Analytical Quality by Design (AQBD), selection of CQAs, CPPs, and parameters to optimize, factorial and Box-Behnken models, data analysis for method validation and transfer, data design and analysis in stability studies, trend analysis.
• Innovation and Continuous Improvement in Quality Laboratories:
• Lean-Kaizen Methodology and Tools in the Laboratory:
Lean Lab: Lean applied to the analytical laboratory, tools: 5S, %W, Poka Joke, Kanban, identifying MUDA in the laboratory, optimizing laboratory costs, Kaizen applied to the laboratory, change management in improvement processes, VSM and A3 tools.
• System Validation and Data Integrity:

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Teaching:

The program utilizes a variety of teaching methods, including:

• In-person sessions: On campus or at company visits.
• Synchronous online sessions: Via video conferencing.
• Interactive sessions: With a focus on participation and discussion.
• Practical exercises: To apply learned concepts.
• Project development: To solidify learning and demonstrate practical application.
The faculty consists of experts in their respective fields, bringing real-world experience and knowledge to the program.

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Careers:

The program prepares participants for leadership roles in quality laboratories across various industries, including:

• Pharmaceutical
• Cosmetic
• Veterinary

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Other:

• The program is semi-presencial, making it compatible with professional and personal schedules.
• The program is bonifiable by Fundae (Fundación Tripartita).
• The program emphasizes analytical laboratory processes.
• The program includes a project component, allowing participants to apply their learning to a real-world initiative.
• The program is designed to have a direct impact on participants' professional lives.
• The program is recognized by Ramon Llull University (URL).
• The program includes a Diploma of University Specialization in Advanced Management of the Quality Laboratory for those who meet the required academic qualifications.