Overview:

Are you working in a role that involves regulatory compliance, equipment validation, or engineering project management in healthcare manufacturing? This two-day intensive course covers everything you need to understand validation, regulatory requirements, and project deliverables. 

On Day 1, you’ll explore foundational principles of validation, including how these principles apply to healthcare, pharmaceutical, and medical device manufacturing. 

On Day 2, you’ll dive into engineering project activities, documentation standards, and the application of risk management across the equipment or system lifecycle.

This course is ideal for professionals new to validation, as well as those looking to deepen their knowledge in regulatory requirements, Good Engineering Practices, and lifecycle risk assessment. 

Past participants have included pharmaceutical manufacturers, medical device developers, and industry suppliers aiming to strengthen their understanding of validation processes.

Content Content:

• History and Importance of Validation: Trace the evolution of validation and its critical role in product quality and regulatory compliance.
  

• Understanding Key Validation Terms: Learn key terminology and concepts, such as training validation, test validation, and training-validation-testing sets.
  

• Regulatory Requirements: Explore the expectations set by European, American, and other global regulatory authorities for validation and quality assurance.
  

• Stages of Validation: Use the 'V' model to break down validation into manageable steps, ensuring clarity on how each stage contributes to compliance.
  

• Engineering Project Deliverables and Documentation: Gain insights into engineering project activities, including URS, DQ, IQ, OQ, PQ, and process validation activities.
  

• Risk Management in Validation: Discover how risk management is applied across the equipment lifecycle, identifying critical points for error prevention.
  

• Factory Acceptance Testing (FAT): Learn best practices for FAT documentation, test witnessing, and hazard identification.
  

• Change Control Management: Understand the importance of Project Change Control and Operational Change Control to maintain product quality throughout equipment life.
  

• Case Studies and Real-World Scenarios: Analyse non-compliant scenarios and discuss corrective actions for workplace improvements.
  

• End of Course Evaluation: Test your understanding with a final assessment and provide feedback on your learning experience.

By the end of this course, you’ll understand how to effectively apply validation principles, ensuring your projects and processes meet the stringent demands of regulatory bodies.