ASTM E2500: A Risk Based Approach to Validation (1 day)

Aims and Objectives
The life sciences industry invests significant resources in qualification and validation compliance. How much of this is real value added? Have you ever questioned whether there is a more effective and efficient approach? This workshop provides an alternative to the historical V Model for qualification and validation using a lean, risk-based approach, based on ASTM E2500 principles.

Learning outcomes and benefits

On successful completion of this course, participants should be able to:

• State the differences between the traditional V model and the ASTM E2500 approach.
• Separate commission and qualification activities
• Apply a risk based model to qualification
• Analyse company programs to identify lean validation opportunities

The participants will be asked to practice some Lean Validation approaches on industry case studies.

Suitability

The course is suitable for all supervisors and managers who work within, or are responsible for qualification, commissioning and validation in the pharmaceuticals, devices and biologics industries. In particular, these include:

• Quality Assurance/Quality Control personnel and managers
• Engineering personnel and managers
• Operations managers and Quality Engineers
• Validation personnel and managers

Participant's notes, case studies and certificates of successful completion will be provided.