Overview:

Are you trying to interpret and understand what validation means? If you read regulatory requirements, either European, American or other countries, does it still leave you puzzled?

It could be that you’re new to the company, role or indeed work for a supplier needing to appreciate what validation means for you and your customers.

The first day of the Understanding Validation Training Course, provides an introduction to help you understand what validation means to the healthcare manufacturing industry. The second day provides an oversight of engineering project activities, deliverables, and documentation. A further explanation is given on how risk management can be utilised throughout the equipment/system life-cycle.

Previous course participants have included people from pharmaceutical and medical device manufacturers and also suppliers to the industry.

Content:

• Understand the history and importance of validation

  • What is validation?

  • Regulatory requirements and expectations

• Understand the terms and the application of validation

  • Discuss the terms used

  • Evaluate the key stages of validation

  • Use the basic 'V' model for a simple approach

• View a CD video and answer questions

  • How far does Good Engineering Practice go towards meeting compliance?

• Use case studies to explore the causes and implications of non compliant validation

  • Analyse real scenarios

  • Determine suitable actions for workplace improvements

• Identify, appreciate and apply risk assessment relative to validation/life-cycle activities

• Establish how engineers’ practices can have significant implications on successful equipment validation projects

  • Recognition of the deliverables in the Validation Plan and final Validation Report detailing compliance to the Validation Plan, through relevance to URS, DQ, IQ, OQ, PQ , process validation activities and the importance of engineering input through these stages

  • Factory Acceptance Testing and documentation practices, including identifying potential hazards

  • Use of test witnesses, best practice testing and documentation requirements, including evidence for verification during qualification

• Understand the importance of Project Change Control and Operational Change Control through the equipment life cycle, to ensure ongoing product quality

• Reflect on overall verification and validation activities for equipment

• End of course evaluation test and feedback