Members' area

Process Validation & Equipment Validation

Organisation profile

SQT are a specialist provider of bespoke training programmes. For over 30 years, we’ve brought the latest thinking, the leading techniques & the most experienced industry experts into ambitious organisations, large & small, throughout Ireland & beyond.

In-House & Public courses in the areas of Continual Process Improvement, Environment & Energy Management, Food Safety, Health & Safety, Hospitals / Medical, Laboratory,Leadership, Lean Six Sigma, Life Sciences, Project Management & Quality

Training aim

• Recognise the regulatory requirements for process validation

• Appreciate the benefits of conducting validation studies

• Demonstrate an understanding of the key elements of process validation

Learning objectives

• Appreciate European & FDA Guidance publications on process validation

• Determine where to use process capability and other statistical methods during validation studies

• Demonstrate an understanding of the approach adopted by the Global Harmonisation Task Force regarding verification and validation

• Design a validation master plan, validation protocols & reports

• Describe the main requirements for maintaining a state of validation

Course outline

Process Validation is required in the Pharmaceutical, API and Medical Device Healthcare Sectors. A comprehensive, well thought-out approach to validation is a key element in assisting any company meet European & US FDA regulatory inspection requirements. This course looks at regulatory guidances & recent trends in validation.