LEARNING & DEVELOPMENT
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Fundamentals of Quality Management System
Fundamentals of Quality Management System
Fundamentals of Quality Management System
- Core principles of Quality Management Systems (QMS), including quality policy, process-based approaches, risk management, and continuous improvement within regulated environments.
- Key QMS elements such as document control, training, deviations, CAPA, change management, audits, and management review to support compliance and operational effectiveness.
- Roles and responsibilities in maintaining a compliant quality culture aligned with GMP, ISO, and applicable regulatory requirements across laboratory and manufacturing operations.
Product Development LifeCycle
Fundamentals of Quality Management System
Fundamentals of Quality Management System
- Overview of the product development lifecycle from concept and feasibility through development, validation, commercialization, and post-market support within regulated life sciences environments.
- Key activities across development stages, including formulation/process development, analytical testing, technology transfer, risk management, and process validation.
- Cross-functional integration of quality, regulatory, manufacturing, and project management practices to ensure compliant, efficient, and successful product development outcomes.
Quality by Design (QbD)
Data Integrity in the Lab Environment
Data Integrity in the Lab Environment
- Principles and regulatory expectations of QbD, including ICH Q8, Q9, and Q10 guidance.
- Identification and application of CQAs, CPPs, risk assessments, and control strategies to ensure product and process quality.
- Use of Design of Experiments (DoE), process understanding, and lifecycle management to support robust and compliant manufacturing processes.
Data Integrity in the Lab Environment
Data Integrity in the Lab Environment
Data Integrity in the Lab Environment
- Core data integrity principles, including ALCOA+ requirements and regulatory expectations for GMP/GLP laboratories.
- Good documentation and electronic data management practices to ensure accurate, complete, and traceable laboratory records.
- Identification and mitigation of data integrity risks during analytical testing, review, investigations, and regulatory inspections.
